FDA Adverse Event
Malfunction
Summary report: N
PROCEDURAL STRETCHER
MDR report key: 3883982
·
Received February 14, 2014
Report
- Report Number
- 3006697241-2014-00147
- Event Type
- Malfunction
- Date Received
- February 14, 2014
- Date of Event
- January 16, 2014
- Report Date
- January 16, 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
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE TECHNICIAN FOUND THE BRAKE CASTER WILL SWIVEL, THE CAUSE IS UNK. THE TECHNICIAN REPLACED THE BRAKE CASTER TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE ACCOUNT REPORTED THE BRAKES ARE NOT FUNCTIONING. THE STRETCHER WAS LOCATED ON THE GROUND FLOOR OF 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 |
|---|---|---|---|---|---|---|---|
| 98103 | PROCEDURAL STRETCHER | WHEELED STRETCHER | FPO | HILLROM DE MEXICO S DE RL DE CV | 8000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |