FDA Adverse Event
Other
Summary report: N
AMBU SPUR II ADULT RESUSCITATOR
MDR report key: 3601989
·
Received January 27, 2014
Report
- Report Number
- MW5034110
- Event Type
- Other
- Date Received
- January 27, 2014
- Date of Event
- January 20, 2014
- Report Date
- January 27, 2014
- Manufacturer
- AMBU INC.
- Product Code
- BTM
- Report Source
- Voluntary report
- Reporter Location
- IL, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
PT REQUIRED AMBU VENTILATION AFTER SEDATION. OPENED UP SEALED AMBU BAG AND THERE WAS NO MASK IN THE BAG. ANOTHER AMBU BAG WAS RETRIEVED. NO HARM TO PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 58433 | AMBU SPUR II ADULT RESUSCITATOR | PATIENT RESUSCITATOR | BTM | AMBU INC. | 1424655 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 86 YR | Other |