FDA Adverse Event
Malfunction
Summary report: N
TRANSTAR STRETCHER
MDR report key: 3844798
·
Received March 12, 2014
Report
- Report Number
- 3006697241-2014-00234
- Event Type
- Malfunction
- Date Received
- March 12, 2014
- Date of Event
- February 12, 2014
- Report Date
- February 12, 2014
- Manufacturer
- HILLROM DE MEXICO S DE RL DE CV
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- UNKNOWN
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE LEFT SIDE RAIL HAS A BROKEN END TUBE, MOST LIKELY DUE TO FORCE SUCH AS THE SIDE RAIL HITTING A DOORWAY DURING TRANSPORT. THE TECHNICIAN REPLACED THE SIDE RAIL END TUBE TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE ACCOUNT REPORTED TO THE LEFT SIDE RAIL WOULD NOT LATCH. THE STRETCHER WAS LOCATED IN THE BASEMENT AT THE FACILITY. 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 |
|---|---|---|---|---|---|---|---|
| 149251 | TRANSTAR STRETCHER | WHEELED STRETCHER | FPO | HILLROM DE MEXICO S DE RL DE CV | 8005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |