FDA Adverse Event
Death
Summary report: N
PED BAG VALVE MASK
MDR report key: 1083552
·
Received July 31, 2008
Report
- Report Number
- MW5007819
- Event Type
- Death
- Date Received
- July 31, 2008
- Date of Event
- July 21, 2008
- Report Date
- July 31, 2008
- Manufacturer
- RUSCH
- Product Code
- BTM
- Report Source
- Voluntary report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
REPORTER REPORTS THAT A 7-MONTH OLD WAS IN CARDIAC ARREST. EMTS WERE CALLED AND THE ONE WAY VALVE DID NOT PROVIDE VENTILATIONS TO PATIENT, AND PATIENT EXPIRED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | PED BAG VALVE MASK | NONE | BTM | RUSCH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 7 MO | Death |