FDA Adverse Event
Summary report: N
V CARE
MDR report key: 2739135
·
Received May 14, 2012
Report
- Report Number
- 2246980-2012-00006
- Date Received
- May 14, 2012
- Date of Event
- March 5, 2012
- Report Date
- March 14, 2012
- Manufacturer
- VENTLAB CORP.
- Product Code
- BTM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- NURSE
Narratives
Description of Event or Problem · 1
PT PRESENTS TO THE ER IN FULL CARDIOPULMONARY ARREST, MEDICS UNABLE TO INTUBATE HER AND PT HAD NO SPONTANEOUS RESPIRATIONS AND NO PULSE PREVIOUS TO TRANSFER INTO EMERGENCY TRAUMA CENTER VIA SQUAD. THE CONNECTOR PIECE ON THE RESUSCITATION BAG SNAPPED OFF WHILE THE RESPIRATORY THERAPIST WAS TRYING TO PLACE THE EZ-PAP. IT DOESN'T APPEAR THAT THIS PIECE IS TYPICALLY LOOSE ON THESE BAGS. ANOTHER DEVICE IMMEDIATELY RETRIEVED AND RESUSCITATION EFFORTS CONTINUED, HOWEVER, PT PRONOUNCED DECEASED SHORTLY THEREAFTER. DEVICE USAGE PROBLEM: DEVICE FAILED (E.G BROKE, COULDN'T GET IT TO WORK OR STOPPED WORKING).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | V CARE | RESUSCITATOR | BTM | VENTLAB CORP. | VN-1000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | OTHER THERAPIES USE ON PT: NOT KNOWN| OTHER DEVICE USE ON PT: UNK |