FDA Adverse Event
Malfunction
Summary report: N
VERSACARE BED
MDR report key: 4862048
·
Received June 15, 2015
Report
- Report Number
- 1824206-2015-00651
- Event Type
- Malfunction
- Date Received
- June 15, 2015
- Date of Event
- May 20, 2015
- Report Date
- May 20, 2015
- Manufacturer
- HILL-ROM, INC.
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICIAN FOUND THERE WERE BENT PINS ON THE COMMUNICATION CABLE. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED FROM 2012-2014. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE COMMUNICATION CABLE 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 NURSE CALL WOULD NOT WORK. THE BED WAS LOCATED IN THE FOUNDERS BUILDING 11TH FLOOR AT THE ACCOUNT. THERE WAS NO PATIENT/USER INJURY REPORTED. THIS REPORTED WAS FILED IN OUR COMPLAINT HANDLING SYSTEM AS COMPLAINT #(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 389890 | VERSACARE BED | A/C POWERED ADJUSTABLE HOSP BED | FNL | HILL-ROM, INC. | 3200 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |