FDA Adverse Event
Malfunction
Summary report: N
1031452-2016-03262
MDR report key: 5865609
·
Received August 10, 2016
Report
- Report Number
- 1031452-2016-03262
- Event Type
- Malfunction
- Date Received
- August 10, 2016
- Report Date
- August 31, 2016
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL/UPDATED INFORMATION WAS ADDED TO REFLECT THE JUNCTION BOX BEING RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RESULT OF THE EVALUATION WAS THAT NO SMOKE OR SPARKS WERE OBSERVED DURING TESTING. HOWEVER, IT WAS EVIDENT THAT THE JUNCTION BOX HAD FAILED AS THERE WAS DAMAGE TO THE C2 CAPACITOR AND THE K3/K6 RELAYS WERE EXPOSED. THE UNDERLYING CAUSE COULD NOT BE DETERMINED.
Additional Manufacturer Narrative · 1
A RETURN WAS ISSUED AND THE PRODUCT IS AWAITING RECEIPT AND/OR EVALUATION. A FOLLOW UP WILL BE FILED IF/WHEN ANY ADDITIONAL INFORMATION IS PROVIDED.
Description of Event or Problem · 1
AN ELECTRICAL COMPONENT OF THE BED WAS SMOKING AND FLAMING.
Description of Event or Problem · 1
AN ELECTRICAL COMPONENT OF THE BED WAS SMOKING AND FLAMING.
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |