FDA Adverse Event
Malfunction
Summary report: N
INVACARE BEDS
MDR report key: 808633
·
Received October 10, 2006
Report
- Report Number
- 1525712-2006-00075
- Event Type
- Malfunction
- Date Received
- October 10, 2006
- Report Date
- October 9, 2006
- Manufacturer
- INVACARE BEDS
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
MANUFACTURER HAS CONTACTED COMPONENT SUPPLIER. COMPONENT SUPPLIER HAS ISSUED MANUFACTURER A FIELD CORRECTION NOTICE. MANUFACTURER'S RISK ASSESSMENT CONCURS WITH THIS COURSE OF ACTION. MANUFACTURER IS WORKING WITH COMPONENT SUPPLIER TO DETERMINE THE EXTENT AND TYPE OF FIELD ACTION REQUIRED. ALL MATERIAL WITHIN THE MANUFACTURER'S CONTROL HAS BEEN INSPECTED AND CORRECTED.
Description of Event or Problem · 1
A REPRESENTATIVE OF A COMPONENT SUPPLIER IMPROPERLY ADJUSTED A QUANTITY OF MOTORIZED ACTUATORS DURING AN UNAUTHORIZED REWORK AT INVACARE'S PRODUCTION FACILITY. THIS ISSUE WAS DISCOVERED DURING FINAL DEVICE PRODUCTION TESTING, AT THE INVACARE MANUFACTURING FACILITY. NO FIELD COMPLAINTS HAVE BEEN RECEIVED REGARDING THE IMPROPER ADJUSTMENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | INVACARE BEDS | 880.5100 | FNL | INVACARE BEDS | 5410 IVC | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |