FDA Adverse Event
Malfunction
Summary report: N
RESQPOD
MDR report key: 2181370
·
Received July 14, 2011
Report
- Report Number
- 2181370
- Event Type
- Malfunction
- Date Received
- July 14, 2011
- Date of Event
- July 11, 2011
- Report Date
- July 14, 2011
- Manufacturer
- ADVANCED CIRCULATORY SYSTEMS, INC
- Product Code
- BWF
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- OK, US
Narratives
Description of Event or Problem · 1
PATIENT INTUBATED DURING CPR. DEVICE ATTACHED TO ET TUBE. DEVICE HAD A LEAK, RESULTING IN NO CHEST RISE. AIR WAS COMING OUT FROM THE DEVICE. SECOND DEVICE WAS ATTACHED WHICH WORKED WITHOUT PROBLEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | RESQPOD | IMPEDANCE THRESHOLD DEVICE | BWF | ADVANCED CIRCULATORY SYSTEMS, INC | * | 7753569 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR |