HEALTHDYNE 900 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-02-25 for HEALTHDYNE 900 * manufactured by Healthdyne.

Event Text Entries

[49291] Premature baby had apneic episode at home. Pt was admitted with diagnosis of apnea and r/o sepsis. On 7/19/96, pt was undergoing pneumogram study and pt was found apneic and pulseless. Resuscitation efforts were unsuccessful. There are conflicting reports regarding if the alarm was sounding or not at the time the baby was found.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 77289
• MDR Report Key: 77289
• Date Received: 1997-02-25
• Date of Report: 1996-07-26
• Date of Event: 1996-07-19
• Date Facility Aware: 1996-07-22
• Report Date: 1996-07-26
• Date Reported to FDA: 1996-07-26
• Date Reported to Mfgr: 1996-07-26
• Date Added to Maude: 1997-03-21
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: HEALTHDYNE
• Generic Name: APNEA MONITOR
• Product Code: FLS
• Date Received: 1997-02-25
• Model Number: 900
• Catalog Number: *
• Lot Number: *
• ID Number: N0310
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: NO INFO
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 76999
• Manufacturer: HEALTHDYNE
• Manufacturer Address: 1255 KENNESTONE CIRCLE MARIETTA GA 30066 US

Device Sequence Number: 2

• Brand Name: HEALTHDYNE
• Generic Name: OXIMETRY MONITOR
• Product Code: DQA
• Date Received: 1997-02-25
• Model Number: 930
• Catalog Number: *
• Lot Number: *
• ID Number: TYPE 03
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 77001
• Manufacturer: HEALTHDYNE
• Manufacturer Address: 1255 KENNESTONE CIRCLE MARIETTA GA 30066 US

Device Sequence Number: 3

• Brand Name: HEALTHDYNE
• Generic Name: DATA RECORDER
• Product Code: DQA
• Date Received: 1997-02-25
• Model Number: 6100
• Catalog Number: *
• Lot Number: *
• ID Number: TYPE 1C
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 77005
• Manufacturer: HEALTHDYNE
• Manufacturer Address: 1255 KENNESTONE CIRCLE MARIETTA GA 30066 US

Device Sequence Number: 4

• Brand Name: SPACELAB
• Generic Name: THERMISTOR & NASAL AIRFLOW MONITOR
• Product Code: MNR
• Date Received: 1997-02-25
• Model Number: 6200
• Catalog Number: *
• Lot Number: TYPE 2
• ID Number: SEQ# 001104
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 4
• Device Event Key: 77007
• Manufacturer: SPACELAB
• Manufacturer Address: * * *

Device Sequence Number: 5

• Brand Name: SYNERGETICS
• Generic Name: GASTRIC MONITOR
• Product Code: FFT
• Date Received: 1997-02-25
• Model Number: PH
• Catalog Number: *
• Lot Number: *
• ID Number: CNST# 939, #00862
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 5
• Device Event Key: 77009
• Manufacturer: SYNERGETICS
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1997-02-25