FDA Adverse Event
Malfunction
Summary report: N
IN TOUCH EU
MDR report key: 3041450
·
Received April 8, 2013
Report
- Report Number
- 0001831750-2013-03007
- Event Type
- Malfunction
- Date Received
- April 8, 2013
- Date of Event
- March 14, 2013
- Report Date
- March 14, 2013
- Manufacturer
- STRYKER MEDICAL-KALAMAZOO
- Product Code
- FNL
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOLLOW-UP SUBMITTED WITH EVALUATION RESULTS PROVIDED BY CUSTOMER WHICH DETERMINED THE BATTERIES HAD SWOLLEN AND FLUID LEAKED OUT OF THE BATTERIES ONTO THE CONTROL BOARD. CUSTOMER PERFORMED EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE FLUID ESCAPED FROM THE BATTERY AND BATTERY BOX, DAMAGING COMPONENTS. NO PATIENT WAS AFFECTED AND NO ADVERSE CONSEQUENCE OR CLINICALLY RELEVANT DELAY IN TREATMENT WAS REPORTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE FLUID ESCAPED FROM THE BATTERY AND BATTERY BOX, DAMAGING COMPONENTS. 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 |
|---|---|---|---|---|---|---|---|
| 142706 | IN TOUCH EU | BED, AC-POWERED ADJUSTABLE HOSPITAL | FNL | STRYKER MEDICAL-KALAMAZOO |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |