FDA Adverse Event
Malfunction
Summary report: N
TOTALCARE BED
MDR report key: 4213230
·
Received October 3, 2014
Report
- Report Number
- 1824206-2014-02387
- Event Type
- Malfunction
- Date Received
- October 3, 2014
- Date of Event
- September 6, 2014
- Report Date
- September 6, 2014
- Manufacturer
- HILL-ROM TECHNICIAN
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICIAN FOUND THE LEFT SIDERAIL WOULD NOT LATCH. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS DID NOT SHOW HILL-ROM PERFORMED ANY PREVENTATIVE MAINTENANCE ON THIS BED. IT IS UNKNOWN IF THE FACILITY PERFORMS PREVENTATIVE MAINTENANCE ON THEIR BEDS. THE TECHNICIAN ADJUSTED THE SIDERAIL TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
HILL-ROM RECEIVED A REPORT FROM THE ACCOUNT STATING THE LEFT SIDERAIL WAS BROKEN (SIDERAIL NOT LATCHING). THE BED WAS LOCATED AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORT WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 619402 | TOTALCARE BED | A/C POWERED ADJUSTABLE HOSPITAL BED | FNL | HILL-ROM TECHNICIAN | 1840 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |