FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE SPO2RT PLUS BED
MDR report key: 2944290
·
Received January 10, 2013
Report
- Report Number
- 1824206-2013-00269
- Event Type
- Malfunction
- Date Received
- January 10, 2013
- Date of Event
- December 28, 2012
- Report Date
- December 28, 2012
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN REPLACED THE CARDIOPULMONARY RESUSCITATION VALVE TO RESOLVE THE ISSUE.
Description of Event or Problem · 1
THE TECHNICIAN ALLEGED THAT THE CARDIOPULMONARY RESUSCITATION WILL NOT ENGAGE. NO PATIENT IMPACT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 16146 | TOTALCARE SPO2RT PLUS BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM, INC. | 1900 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |