FDA Adverse Event
Malfunction
Summary report: N
TRU-SAT
MDR report key: 1443252
·
Received July 29, 2009
Report
- Report Number
- 1443252
- Event Type
- Malfunction
- Date Received
- July 29, 2009
- Date of Event
- July 6, 2009
- Report Date
- July 29, 2009
- Manufacturer
- GE MEDICAL SYSTEMS, LLC
- Product Code
- DQA
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- IA, US
Narratives
Description of Event or Problem · 1
PATIENT CABLE THAT CONNECTS PROBE TO PULSE OXIMETER FAILED.MANUFACTURER RESPONSE (AS PER REPORTER) FOR PULSE OXIMETER, TRU-SAT:MANUFACTURER INSISTS THAT THE CABLES ARE MEETING EXPECTED LIFE SPAN, HOWEVER, WE KNOW OF NO INFORMATION THAT IS CURRENTLY GIVEN TO PATIENT (IN OPERATOR'S MANUAL) THAT SUGGESTS THESE NEED TO BE REPLACED PERIODICALLY OR ON A ROUTINE BASIS. THIS RESULTS IN REPLACEMENT ONLY AFTER DEVICE FAILS WHICH IS DANGEROUS BASED UPON THE SENSITIVE NATURE AND INTENT OF THIS PRODUCT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRU-SAT | PULSE OXIMETER | DQA | GE MEDICAL SYSTEMS, LLC | OXY-MC3 | 28008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 12 YR |