FDA Adverse Event
Malfunction
Summary report: N
OUT PATIENT REGU-GAGE
MDR report key: 1003928
·
Received January 31, 2008
Report
- Report Number
- 1003928
- Event Type
- Malfunction
- Date Received
- January 31, 2008
- Date of Event
- December 20, 2007
- Report Date
- January 31, 2008
- Manufacturer
- ALLIED HEALTH CARE PRODUCTS, INC.
- Product Code
- GCX
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- TN, US
Narratives
Description of Event or Problem · 1
THE SUCTION EQUIPMENT WAS CHECKED PRIOR TO THE BEGINNING OF THE PROCEDURE, AND WAS IN WORKING ORDER. THE SUCTION EQUIPMENT WORKED THE FIRST TIME IT WAS NEEDED. HOWEVER, THE PHYSICIAN STATED THAT IT DID NOT SEEM TO SUCTION CORRECTLY THE FIRST TIME, THOUGH THE NURSE INVOLVED IN THIS CASE DISPUTES THIS STATEMENT. THE SECOND TIME THE SUCTION DEVICE WAS USED, THE EQUIPMENT FAILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | OUT PATIENT REGU-GAGE | GENERATOR, SUCTION | GCX | ALLIED HEALTH CARE PRODUCTS, INC. | * | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 50 YR | SUCTION TUBING. BIOMED DID DETERMINE THAT THE FAIL| NO OTHER THERAPIES| NONE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE| NO OTHER THERAPIES| CANISTER OR TUBING.| CANISTER OR TUBING.| ON EQUIPMENT HAS THE SUCTION DEVICE, CANISTER AND| SUCTION TUBING. BIOMED DID DETERMINE THAT THE FAIL| URE WAS DUE TO THE SUCTION EQUIPMENT, AND NOT THE| URE WAS DUE TO THE SUCTION EQUIPMENT, AND NOT THE| EVENT, BUT THE TEE PROBE WAS BEING USED. THE SUCTI| NONE THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE| ON EQUIPMENT HAS THE SUCTION DEVICE, CANISTER AND| EVENT, BUT THE TEE PROBE WAS BEING USED. THE SUCTI |