RESPIRONICS BIPAP S/T 332203 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-10-18 for RESPIRONICS BIPAP S/T 332203 * manufactured by Respironics, Inc..

Event Text Entries

[17800246] Child was rooming in with mother in the pediatric intermediate intensive care unit in preparation for discharge. On trach collar during the day, connected to bipap during night time hours. Mother summoned help, claims bipap was disconnected from trach and did not hear alarm. Claims she heard pulse ox alarm. Staff responded immediately. Resuscitation efforts were unsuccessful.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 245199
• MDR Report Key: 245199
• Date Received: 1999-10-18
• Date of Report: 1999-10-18
• Date of Event: 1999-10-13
• Date Facility Aware: 1999-10-13
• Report Date: 1999-10-18
• Date Reported to Mfgr: 1999-10-18
• Date Added to Maude: 1999-10-20
• 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: RESPIRONICS
• Generic Name: POSITIVE AIRWAY PRESSURE MACHINE
• Product Code: BZD
• Date Received: 1999-10-18
• Model Number: BIPAP S/T 332203
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 237557
• Manufacturer: RESPIRONICS, INC.
• Manufacturer Address: 1501 ARDMORE BLVD. PITTSBURG PA 15221 US
• Baseline Brand Name: BIPAP S/T DOMESTIC HOME SYSTEM
• Baseline Generic Name: NON-CONTINUOUS VENTILATION
• Baseline Model No: 1000984
• Baseline Catalog No: 1000984
• Baseline ID: NA
• Baseline Device Family: BIPAP S/T
• Baseline Shelf Life Contained: *
• Baseline Shelf Life [Months]: *
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K883825
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Device Sequence Number: 2

• Brand Name: RESPIRONICS
• Generic Name: POSITIVE AIRWAY PRESSURE MACHINE
• Product Code: CAP
• Date Received: 1999-10-18
• Model Number: AIRWAY PRESSURE MONITOR 302220
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: UNKNOWN
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 237560
• Manufacturer: RESPIRONICS, INC.
• Manufacturer Address: 1501 ARDMORE BLVD. PITTSBURG PA 15221 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1999-10-18