FDA Adverse Event
Malfunction
Summary report: N
T1500 GLOBETROTTER
MDR report key: 182894
·
Received August 13, 1998
Report
- Report Number
- 2510954-1998-00005
- Event Type
- Malfunction
- Date Received
- August 13, 1998
- Date of Event
- July 14, 1998
- Report Date
- July 16, 1998
- Manufacturer
- HILL-ROM AIR-SHIELDS
- Product Code
- FMZ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- SERVICE PERSONNEL
Narratives
Description of Event or Problem · 1
HILL-ROM AIR SHIELDS DISTRIBUTOR IN AUSTRALIA WAS NOTIFIED BY A HOSP THAT WHILE CONDUCTING NORMAL PROCEDURES AN OXYGEN CYLINDER VALVE WAS OPENED AND WAS IMMEDIATELY FOLLOWED BY A LOUD NOISE. SPARKS WERE REPORTED TO HAVE BEEN SIGHTED. THE OXYGEN CYLINDER VALVE WAS THEN CLOSED, WHICH IMMEDIATELY TERMINATED THE SITUATION. THERE WERE NO INJURIES ASSOCIATED WITH THIS PRODUCT PROBLEM REPORT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | T1500 GLOBETROTTER | TRANSPORT INCUBATOR SYS | FMZ | HILL-ROM AIR-SHIELDS | GT500 | * |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN |