FDA Adverse Event
Malfunction
Summary report: N
AFFINITY THREE BIRTHING BED
MDR report key: 3240990
·
Received July 17, 2013
Report
- Report Number
- 1824206-2013-03538
- Event Type
- Malfunction
- Date Received
- July 17, 2013
- Date of Event
- June 20, 2013
- Report Date
- June 20, 2013
- Manufacturer
- HILL-ROM INC.
- Product Code
- HDD
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE ACCOUNT FOUND THE LABEL ON THE RIGHT SIDE RAIL NURSE CONTROLS IS DAMAGED SO IS THE RIGHT SIDE RAIL CONTROL BOARD. THE ACCOUNT FOUND THE POWER CORD TO THE BED IS MISSING. THE ACCOUNT REPLACED THE RIGHT SIDE RAIL POWER CONTROL BOARD AND THE POWER CORD TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE ACCOUNT ALLEGED THE HEAD GOES DOWN ON ITS OWN. NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 332964 | AFFINITY THREE BIRTHING BED | BIRTHING BED | HDD | HILL-ROM INC. | 3700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |