FDA Adverse Event
Death
Summary report: N
UNOMEDICAL INC DISTRIBUTED BY KENTRON HEALTH
MDR report key: 2280990
·
Received September 16, 2011
Report
- Report Number
- 2280990
- Event Type
- Death
- Date Received
- September 16, 2011
- Date of Event
- September 9, 2011
- Report Date
- September 13, 2011
- Manufacturer
- UNOMEDICAL, INC.
- Product Code
- BTM
- Report Source
- User Facility report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
ON THE FIRST TREATMENT THE PT HAD A RESPIRATORY ARREST WITHIN 15 MINUTES OF TREATMENT START. BLOOD PRESSURE AND PULSE NOTED WITH NO RESPIRATIONS. AMBU BAGGING INITIATED USING BLUE COLOURED UNOMEDICAL, INC. AMBU BAG LOT 04-40 DISTRIBUTED BY (B)(4). THE AMBU BAG FAILED TO PROVIDE POSITIVE PRESSURE VENTILATION AND WAS IMMEDIATELY REPLACED WITH ANOTHER AMBU BAG FROM A DIFFERENT COMPANY UNTIL EMS ARRIVED IN FIVE MINUTES. PT TRANSPORTED BY EMS TO LOCAL HOSPITAL WHERE SHE EXPIRED. THIS AMBU BAG DISTRIBUTED PER PRODUCTION LITERATURE INSRT PROVIDED BY; (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNOMEDICAL INC DISTRIBUTED BY KENTRON HEALTH | AMBU BAG | BTM | UNOMEDICAL, INC. | 778500 | 04-40 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | Death| R |