FDA Adverse Event
Malfunction
Summary report: N
PROCEDURAL STRETCHER
MDR report key: 3932166
·
Received April 3, 2014
Report
- Report Number
- 3006697241-2014-00303
- Event Type
- Malfunction
- Date Received
- April 3, 2014
- Date of Event
- March 4, 2014
- Report Date
- March 4, 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 SIDE RAIL LATCH PLATE IS BENT. THE MOST LIKELY CAUSE OF A BENT LATCH PLATE IS FORCE SUCH AS THE SIDE RAIL WAS RAN INTO AN OBJECT DURING TRANSPORT. A SEARCH OF THE HILL-ROM MAINTENANCE RECORDS SHOWED HILL-ROM PERFORMED PREVENTATIVE MAINTENANCE ON THIS BED IN 2013 AND 2014. IT IS UNKNOWN IF THE FACILITY PERFORMED ANY OTHER PREVENTATIVE MAINTENANCE ON THIS BED. THE TECHNICIAN REPLACED THE SIDE RAIL LATCH TO RESOLVE THE ISSUE. BASED ON TIS INFORMATION, NO FURTHER ACTION IS REQUIRED.
Description of Event or Problem · 1
THE ACCOUNT REPORTED THE SIDE RAIL WILL NOT LATCH. THE STRETCHER IS LOCATED IN THE HALL 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 |
|---|---|---|---|---|---|---|---|
| 200647 | PROCEDURAL STRETCHER | WHEELED STRETCHER | FPO | HILLROM DE MEXICO S DE RL DE CV | 8005 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |