FDA Adverse Event
Malfunction
Summary report: N
BED, MANUAL
MDR report key: 2955870
·
Received February 11, 2013
Report
- Report Number
- 1525712-2013-01008
- Event Type
- Malfunction
- Date Received
- February 11, 2013
- Report Date
- February 11, 2013
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- FNJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). MDR HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.
Additional Manufacturer Narrative · 1
(B)(4). MDR HAS BEEN INITIATED FOR THIS ISSUE. THE MALFUNCTION HAS NOT BEEN CONFIRMED.
Description of Event or Problem · 1
PER (B)(6) NEW CS7 BED AND THE RAIL WAS SO LOOSE, IT FELL OFF THE BED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 59592 | BED, MANUAL | 880.5120 | FNJ | INVACARE TAYLOR STREET | CS7 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |