BIPAP VENTILATOR ST #332203 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-03-12 for BIPAP VENTILATOR ST #332203 * manufactured by Respironics, Inc..

Event Text Entries

[44542] The pt was a 2 1/2 yr old girl who had been born with severe birth defects including a fused esophagus and trachea. For about 19 months before the incident, the child had been a pt at a chronic rehabilitation hosp. During the day, the pt had been on mist to her tracheotomy tube. At night, she required ventilation support and was connected to a ventilation system as well as cardiac and respiratory monitoring and alarm systems. On the evening of 10/10/96 for reasons that have not yet been determined, the tubing connecting the pt to the ventilation system became disconnected at the heater unit, and the pt had a cardiac arrest. While no final conclusions can be drawn at this time, certain info gives rise to a preliminary determination that a defect in the ventilation system as well as the related monitors and alarms systems may have caused or contributed to the incident. The medical staff was able to regain the pt's heart rate, but she had no spontaneous respirations. After stabilization, the pt was transferred to the icu of another hosp where it was determined that the pt had suffered severe anoxic injury. Two days after the incident, the pt's parents decided to withdraw life support, after which the pt died.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 76714
• MDR Report Key: 76714
• Date Received: 1997-03-12
• Date of Report: 1997-03-12
• Date of Event: 1996-10-10
• Report Date: 1997-03-12
• Date Reported to FDA: 1997-03-12
• Date Reported to Mfgr: 1997-03-12
• Date Added to Maude: 1997-03-19
• 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
• Reporter Occupation: RESPIRATORY THERAPIST
• 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: BIPAP VENTILATOR
• Generic Name: SUPPORT SYSTEM
• Product Code: BZD
• Date Received: 1997-03-12
• Model Number: ST #332203
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Device Availability: *
• Device Age: NO INFO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 76432
• Manufacturer: RESPIRONICS, INC.
• Manufacturer Address: 1001 MURRAY RIDGE DR MURRYSVILLE PA 156688550 US
• Baseline Brand Name: BIPAP S/T DOMESTIC HOME SYSTEM
• Baseline Generic Name: NON CONTINUOUS VENTILATOR
• Baseline Model No: 332203
• Baseline Catalog No: 332074
• Baseline ID: NA
• Baseline Device Family: BIPAP S/T
• Baseline Shelf Life Contained: *
• Baseline Shelf Life [Months]: NA
• 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: CONCHA THERM III
• Generic Name: HEATER
• Product Code: BTT
• Date Received: 1997-03-12
• Model Number: *
• Catalog Number: 380-80
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: NO INFO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 76435
• Manufacturer: HUDSON RESPIRATORY CARE
• Manufacturer Address: 27711 DIAZ RD TEMECULA CA 92390 US

Device Sequence Number: 3

• Brand Name: MONAGHAM AIRWAY PRESSURE MONITOR
• Generic Name: AIRWAY PRESSURE MONITOR
• Product Code: CAP
• Date Received: 1997-03-12
• Model Number: CM 5000
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: NO INFO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 3
• Device Event Key: 76438
• Manufacturer: CANADIAN MONAGHAN LTD
• Manufacturer Address: 920 LEATHORNE ST LONDON, ONTARIO CA N573M5

Device Sequence Number: 4

• Brand Name: ESCORT
• Generic Name: ESCORT MONITORING SYSTEM
• Product Code: DRT
• Date Received: 1997-03-12
• Model Number: E-100
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: NO INFO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 4
• Device Event Key: 76442
• Manufacturer: MEDICAL DATA ELECTRONICS, INC.
• Manufacturer Address: 127020 WENTWORTH ST ARLETA CA 913314309 US

Device Sequence Number: 5

• Brand Name: ESCORT
• Generic Name: BASE MONITOR
• Product Code: DRT
• Date Received: 1997-03-12
• Model Number: E 3200OC
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: NO INFO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 5
• Device Event Key: 76445
• Manufacturer: MEDICAL DATA ELECTRONICS, INC.
• Manufacturer Address: 12720 WENTWORTH ST ARLETA CA 913314309 US

Device Sequence Number: 6

• Brand Name: ESCORT
• Generic Name: LINK MONITOR
• Product Code: DRT
• Date Received: 1997-03-12
• Model Number: 3202-01
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: *
• Device Age: NO INFO
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 6
• Device Event Key: 76446
• Manufacturer: MEDICAL DATA ELECTRONICS. INC.
• Manufacturer Address: 127020 WENTWORTH ST ARLETA CA 913314309 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Congenital Not Applicablenomaly; 2. Hospitalization; 3. Life Threatening; 4. Other; 5. Required No Informationntervention; 6. Deathisabilit	1997-03-12