FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER 2007HZ

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-06-26 for FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER 2007HZ manufactured by Hudson Rci, Teleflex Medical.

MAUDE Entry Details

• Report Number: MW5087643
• MDR Report Key: 8739528
• Date Received: 2019-06-26
• Date of Report: 2019-06-24
• Date of Event: 2019-06-13
• Date Added to Maude: 2019-06-27
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: RISK MANAGER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Sequence Number: 1

• Brand Name: FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER
• Generic Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION)
• Product Code: BTM
• Date Received: 2019-06-26
• Catalog Number: 2007HZ
• Lot Number: 316763
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: I
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: HUDSON RCI, TELEFLEX MEDICAL
• Manufacturer Address: MORRISVILLE NC 27560 US 27560

Device Sequence Number: 2

• Brand Name: FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER
• Generic Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION)
• Product Code: BTM
• Date Received: 2019-06-26
• Catalog Number: 2007HZ
• Lot Number: 317232
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 2
• Device Event Key: 0
• Manufacturer: HUDSON RCI, TELEFLEX MEDICAL
• Manufacturer Address: MORRISVILLE NC 27560 US 27560

Device Sequence Number: 3

• Brand Name: FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER
• Generic Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION)
• Product Code: BTM
• Date Received: 2019-06-26
• Catalog Number: 2007HZ
• Lot Number: 317232
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 3
• Device Event Key: 0
• Manufacturer: HUDSON RCI, TELEFLEX MEDICAL
• Manufacturer Address: MORRISVILLE NC 27560 US 27560

Device Sequence Number: 4

• Brand Name: FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER
• Generic Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION)
• Product Code: BTM
• Date Received: 2019-06-26
• Catalog Number: 2007HZ
• Lot Number: 317232
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 4
• Device Event Key: 0
• Manufacturer: HUDSON RCI, TELEFLEX MEDICAL
• Manufacturer Address: MORRISVILLE NC 27560 US 27560

Device Sequence Number: 5

• Brand Name: FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER
• Generic Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION)
• Product Code: BTM
• Date Received: 2019-06-26
• Catalog Number: 2007HZ
• Lot Number: 317645
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 5
• Device Event Key: 0
• Manufacturer: HUDSON RCI, TELEFLEX MEDICAL
• Manufacturer Address: MORRISVILLE NC 27560 US 27560

Device Sequence Number: 6

• Brand Name: FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER
• Generic Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION)
• Product Code: BTM
• Date Received: 2019-06-26
• Catalog Number: 2007HZ
• Lot Number: 317645
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 6
• Device Event Key: 0
• Manufacturer: HUDSON RCI, TELEFLEX MEDICAL
• Manufacturer Address: MORRISVILLE NC 27560 US 27560

Device Sequence Number: 7

• Brand Name: FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER
• Generic Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION)
• Product Code: BTM
• Date Received: 2019-06-26
• Catalog Number: 2007HZ
• Lot Number: 317645
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 7
• Device Event Key: 0
• Manufacturer: HUDSON RCI, TELEFLEX MEDICAL
• Manufacturer Address: MORRISVILLE NC 27560 US 27560

Device Sequence Number: 8

• Brand Name: FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER
• Generic Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION)
• Product Code: BTM
• Date Received: 2019-06-26
• Catalog Number: 2007HZ
• Lot Number: 317645
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 8
• Device Event Key: 0
• Manufacturer: HUDSON RCI, TELEFLEX MEDICAL
• Manufacturer Address: MORRISVILLE NC 27560 US 27560

Device Sequence Number: 9

• Brand Name: FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER
• Generic Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION)
• Product Code: BTM
• Date Received: 2019-06-26
• Catalog Number: 2007HZ
• Lot Number: 317645
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 9
• Device Event Key: 0
• Manufacturer: HUDSON RCI, TELEFLEX MEDICAL
• Manufacturer Address: MORRISVILLE NC 27560 US 27560

Device Sequence Number: 10

• Brand Name: FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER
• Generic Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION)
• Product Code: BTM
• Date Received: 2019-06-26
• Catalog Number: 2007HZ
• Lot Number: 317645
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 10
• Device Event Key: 0
• Manufacturer: HUDSON RCI, TELEFLEX MEDICAL
• Manufacturer Address: MORRISVILLE NC 27560 US 27560

Device Sequence Number: 11

• Brand Name: FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER
• Generic Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION)
• Product Code: BTM
• Date Received: 2019-06-26
• Catalog Number: 2007HZ
• Lot Number: 318787
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 11
• Device Event Key: 0
• Manufacturer: HUDSON RCI, TELEFLEX MEDICAL
• Manufacturer Address: MORRISVILLE NC 27560 US 27560

Device Sequence Number: 12

• Brand Name: FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER
• Generic Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION)
• Product Code: BTM
• Date Received: 2019-06-26
• Catalog Number: 2007HZ
• Lot Number: 318787
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 12
• Device Event Key: 0
• Manufacturer: HUDSON RCI, TELEFLEX MEDICAL
• Manufacturer Address: MORRISVILLE NC 27560 US 27560

Device Sequence Number: 13

• Brand Name: FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER
• Generic Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION)
• Product Code: BTM
• Date Received: 2019-06-26
• Catalog Number: 2007HZ
• Lot Number: 318787
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 13
• Device Event Key: 0
• Manufacturer: HUDSON RCI, TELEFLEX MEDICAL
• Manufacturer Address: MORRISVILLE NC 27560 US 27560

Device Sequence Number: 14

• Brand Name: FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER
• Generic Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION)
• Product Code: BTM
• Date Received: 2019-06-26
• Catalog Number: 2007HZ
• Lot Number: 318787
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 14
• Device Event Key: 0
• Manufacturer: HUDSON RCI, TELEFLEX MEDICAL
• Manufacturer Address: MORRISVILLE NC 27560 US 27560

Device Sequence Number: 15

• Brand Name: FLOW INFLATING INFANT AMBU BAG 1/2L HYPERINFLATION SYSTEM WITH MANOMETER
• Generic Name: VENTILATOR, EMERGENCY, MANUAL (RESUSCITATION)
• Product Code: BTM
• Date Received: 2019-06-26
• Catalog Number: 2007HZ
• Lot Number: 318787
• Device Availability: *
• Device Eval'ed by Mfgr: I
• Device Sequence No: 15
• Device Event Key: 0
• Manufacturer: HUDSON RCI, TELEFLEX MEDICAL
• Manufacturer Address: MORRISVILLE NC 27560 US 27560

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-06-26