FDA Adverse Event
Malfunction
Summary report: N
PROCEDURAL STRETCHER
MDR report key: 3883325
·
Received February 20, 2014
Report
- Report Number
- 3006697241-2014-00171
- Event Type
- Malfunction
- Date Received
- February 20, 2014
- Date of Event
- January 23, 2014
- Report Date
- January 23, 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 RIGHT SIDE RAIL END TUBE IS BROKEN IN HALF. FOR THE RIGHT SIDE RAIL END TUBE TO BE BROKEN IN HALF, IT WOULD MOST LIKELY HAVE TO BE CAUSED BY ABUSE, SUCH AS THE HOSPITAL STAFF RUNNING THE STRETCHER INTO SOMETHING DURING TRANSPORT. THE TECHNICIAN REPLACED THE RIGHT SIDE RAIL END TUBE TO RESOLVE THE ISSUE. BASED ON THIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE TECHNICIAN REPORTED THE RIGHT SIDE RAIL WILL NOT LATCH. THE BED IS LOCATED ON THE FIRST FLOOR 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 |
|---|---|---|---|---|---|---|---|
| 107698 | PROCEDURAL STRETCHER | WHEELED STRETCHER | FPO | HILLROM DE MEXICO S DE RL DE CV | 8000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |