FDA Adverse Event
Malfunction
Summary report: N
TRANSTAR STRETCHER
MDR report key: 3973292
·
Received June 6, 2014
Report
- Report Number
- 3006697241-2014-00495
- Event Type
- Malfunction
- Date Received
- June 6, 2014
- Date of Event
- May 9, 2014
- Report Date
- May 9, 2014
- Manufacturer
- HILLROM DE MEXICO S DE RL DE CV
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE HILL-ROM TECHNICIAN FOUND ONE CASTER NOT HOLDING DUE TO THE BRAKE CASTER SPINDLE NEEDS TO BE ADJUSTED TO TIGHTEN BRAKES. 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 ALL 4 BRAKE CASTER SPINDLE 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 BRAKES ARE NOT HOLDING. THE BED WAS LOCATED AT THE ACCOUNT IN THE BASEMENT. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 331456 | TRANSTAR STRETCHER | WHEELED STRETCHER | FPO | HILLROM DE MEXICO S DE RL DE CV | 8000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |