FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE
MDR report key: 2002102
·
Received February 4, 2011
Report
- Report Number
- 1824206-2011-00654
- Event Type
- Malfunction
- Date Received
- February 4, 2011
- Date of Event
- January 22, 2011
- Report Date
- January 22, 2011
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
TECHNICIAN FOUND LOOSE PINS IN P379 CABLE CONNECTOR. REPLACED P379 CABLE (B)(4) AND CHECKED FUNCTIONS TO RESOLVE THIS ISSUE.
Description of Event or Problem · 1
COMPLAINANT ALLEGED THAT THE PT IN MEDSURG ROOM CAN PLACE NURSE CALL WITH RESPONSE NOT HEARD IN EXPECTED LOCATION. NO INJURY ALLEGED BY ACCOUNT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TOTALCARE | TOTAL CARE | FNL | HILL-ROM, INC. | P1900B000153 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |