FDA Adverse Event
Injury
Summary report: N
35A AMBULANCE COT
MDR report key: 4066325
·
Received August 26, 2014
Report
- Report Number
- 1523574-2014-00017
- Event Type
- Injury
- Date Received
- August 26, 2014
- Date of Event
- July 13, 2014
- Report Date
- August 25, 2014
- Manufacturer
- FERNO-WASHINGTON, INC.
- Product Code
- FPO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE WAS EVALUATED ON (B)(4) 2014 BY (B)(4), ON BEHALF OF THE MFR. NO DEFECTS OR MALFUNCTIONS COULD BE FOUND. THE INCIDENT COULD NOT BE DUPLICATED. THE UNIT WAS OPERATING ACCORDING TO SPECIFICATIONS. NO FURTHER INFO WAS PROVIDED TO MFR PERTAINING TO PT INJURY AND/OR MEDICAL TREATMENT SOUGHT OUTSIDE OF THE ORIGINAL REASON FOR DISPATCH.
Description of Event or Problem · 1
PT WAS WALKED WITH ASSISTANCE TO THE STRETCHER. STRETCHER AS APPROX 1 FT FROM FLOOR. WHEN PT SAT ON SIDE OF STRETCHER WITH HIS FEET STILL ON THE FLOOR, THE UNIT LOWERED TO FLOOR LEVEL. PT INDICATED THAT IT AGGRAVATED HIS LOWER BACK PAIN, BUT HAD NO OTHER COMPLAINTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 515558 | 35A AMBULANCE COT | 35A AMBULANCE COT | FPO | FERNO-WASHINGTON, INC. | 0012079 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 88 YR | Other |