FDA Adverse Event
Death
Summary report: N
BIPAP S/T
MDR report key: 1387520
·
Received May 15, 2009
Report
- Report Number
- 2518422-2009-00021
- Event Type
- Death
- Date Received
- May 15, 2009
- Date of Event
- April 15, 2009
- Report Date
- April 15, 2009
- Manufacturer
- RESPIRONICS INC.
- Product Code
- MNS
- PMA / PMN Number
- K031656
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
A DURABLE MEDICAL EQUIPMENT SUPPLIER (DME) REPORTED THAT A PATIENT RECEIVING THERAPY FROM A BI-LEVEL CONTINUOUS POSITIVE AIRWAY PRESSURE DEVICE EXPIRED WHILE RECEIVING BIPAP THERAPY. THE CAREGIVER REPORTED THE DEVICE DID NOT PRODUCE AN ALARM TO NOTIFY THEM OF THE EVENT. THE MANUFACTURER IS INVESTIGATING THIS ISSUE AND WILL FILE A FOLLOW-UP WHEN THE INVESTIGATION IS COMPLETED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | BIPAP S/T | VENTILATOR, CONTINUOUS NON-LIFE-SUPPORTING | MNS | RESPIRONICS INC. | 1014248 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Death |