FDA Adverse Event
Malfunction
Summary report: N
CS BED 9153650455
MDR report key: 4861864
·
Received June 23, 2015
Report
- Report Number
- 3003433498-2015-00090
- Event Type
- Malfunction
- Date Received
- June 23, 2015
- Report Date
- June 19, 2015
- Manufacturer
- INVACARE CONTINUING CARE
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
A FOLLOW UP WILL BE SENT IF THE PRODUCT OR ADDITIONAL INFORMATION IS OBTAINED.
Description of Event or Problem · 1
(B)(6) STATED, THAT HALF OF THE WHEEL BREAKS OFF WHEN MOVING THE BEDS ACROSS THE CARPET, BECAUSE HE BELIEVES THERE IS NOT ENOUGH RESISTANCE AND THEY DO NOT SWIVEL WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 407128 | CS BED 9153650455 | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | INVACARE CONTINUING CARE | IHCS7 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |