FDA Adverse Event
Malfunction
Summary report: N
M-1 COT - BASE HIGH LOAD 28
MDR report key: 3082698
·
Received April 29, 2013
Report
- Report Number
- 0001831750-2013-03831
- Event Type
- Malfunction
- Date Received
- April 29, 2013
- Date of Event
- February 5, 2013
- Report Date
- April 3, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FPO
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
(B)(4): THIRD PARTY EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE HEAD END OF THE COT DROPPED TOWARD THE GROUND. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 184455 | M-1 COT - BASE HIGH LOAD 28 | STRETCHER, WHEELED | FPO | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |