FDA Adverse Event
Malfunction
Summary report: N
IMMERSION HYDROBATH
MDR report key: 3013785
·
Received March 20, 2013
Report
- Report Number
- 1525712-2013-02117
- Event Type
- Malfunction
- Date Received
- March 20, 2013
- Report Date
- February 20, 2013
- Manufacturer
- INVACARE TAYLOR STREET
- Product Code
- ILJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Narratives
Description of Event or Problem · 1
(B)(4). NO SERIOUS INJURY ALLEGED. MALFUNCTION ALLEGED. FACILITY REPRESENTATIVE, FROM THEIR MAINTENANCE STAFF, STATES THE JET MOTOR HAS TO BE REPLACED. MDR FILED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 115345 | IMMERSION HYDROBATH | 890.5100 | ILJ | INVACARE TAYLOR STREET | IH3602GXL |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |