FDA Adverse Event
Malfunction
Summary report: N
TRANSTAR STRETCHER
MDR report key: 3952179
·
Received May 13, 2014
Report
- Report Number
- 3006697241-2014-00441
- Event Type
- Malfunction
- Date Received
- May 13, 2014
- Date of Event
- April 14, 2014
- Report Date
- April 14, 2014
- Manufacturer
- HILLROM DE MEXICO S DE RL DE CV
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE BRAKE CASTER PADS ARE NOT MAKING GOOD CONTACT WITH THE TIRES. THE BRAKE CASTER PADS AND TIRES ARE WORN MOST LIKELY DUE TO NORMAL WEAR AND TEAR. 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 REPLACED THE BRAKE CASTERS TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE TECHNICIAN REPORTED THE BRAKE CASTERS ARE ROLLING IN BRAKE MODE. THE BED WAS LOCATED AT THE FACILITY. THERE WAS NO PATIENT/USER INJURY REPORTED. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 286616 | TRANSTAR STRETCHER | WHEELED STRETCHER | FPO | HILLROM DE MEXICO S DE RL DE CV | 8000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |