FDA Adverse Event
Other
Summary report: N
AFFINITY 1 & 2 BED
MDR report key: 2904654
·
Received January 3, 2013
Report
- Report Number
- 1824206-2013-00035
- Event Type
- Other
- Date Received
- January 3, 2013
- Date of Event
- December 13, 2012
- Report Date
- December 13, 2012
- Manufacturer
- HILL-ROM, INC.
- Product Code
- HDD
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECH INSPECTED THE BED AND FOUND NO ANOMALIES WITH THE FOOT SECTION. IT IS LATCHING PROPERLY. HE IN-SERVICED THE NURSES ON HOW TO LATCH THE FOOT SECTION PROPERLY TO PREVENT IT FROM FALLING AGAIN. THERE ARE NO ALLEGED INJURIES REPORTED IN REGARDS TO THIS PROBLEM.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THAT A MOTHER WAS CHANGING HER BABY ON THE END OF THE BED. AS SOON AS SHE PICKED UP THE BABY, THE REMOVABLE FOOT SECTION OF THE BED FELL TO THE GROUND. THERE ARE NO ALLEGED INJURIES REPORTED IN REGARDS TO THIS ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3370 | AFFINITY 1 & 2 BED | BIRTHING BED | HDD | HILL-ROM, INC. | 3600 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Other |