FDA Adverse Event
Malfunction
Summary report: N
POWERLED
MDR report key: 3853607
·
Received April 3, 2014
Report
- Report Number
- 9710055-2014-00018
- Event Type
- Malfunction
- Date Received
- April 3, 2014
- Date of Event
- March 5, 2014
- Report Date
- March 6, 2014
- Manufacturer
- MAQUET SAS
- Product Code
- FSY
- PMA / PMN Number
- K070442
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
AFTER THE EVENT THE FACILITY EQUIPMENT TECH REINSTALLED THE CAP (A.K.A. BUMPER) AND RETURNED THE UNIT TO SERVICE. A MAQUET TECH INSPECTED THE LIGHTING CONFIGURATION FOUND NO ISSUES WITH THE DEVICE. PHOTOS WERE PROVIDED TO MAQUET TO ASSIST WITH THE INVESTIGATION. ACCORDING TO TESTS PERFORMED DURING DESIGN VERIFICATION ACTIVITIES. THIS TYPE OF FAILURE CAN BE CAUSED BY REPEATED COLLISIONS/ IMPACTS TO THE CUPOLA. THE POWERED SERIES OPERATING MANUAL INCLUDES A VERIFICATION OF THE BUMPERS DURING YEARLY MAINTENANCE.
Description of Event or Problem · 1
THE HOSP REPORTED THAT THE RUBBER END CAP FELL OFF OF THE LIGHT DURING A HAND SURGERY IN THE OPERATING ROOM #1. THE PART DID NOT FALL INTO STERILE FIELD. NO INJURY OR ADVERSE EFFECTS WERE REPORTED TO MAQUET. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 203632 | POWERLED | FSY | MAQUET SAS | PWD53+DFHDK3 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA |