FDA Adverse Event
Malfunction
Summary report: N
SYSTEM 2000
MDR report key: 2894360
·
Received December 27, 2012
Report
- Report Number
- 9611530-2012-00222
- Event Type
- Malfunction
- Date Received
- December 27, 2012
- Date of Event
- November 30, 2012
- Report Date
- December 3, 2012
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- ILJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY ARJOHUNTLEIGH, INC. ON BEHALF OF THE MANUFACTURER ARJO (B)(4).
Description of Event or Problem · 1
PER THE ARJOHUNTLEIGH FIELD SERVICE REP'S IDF EVENT DESCRIPTION: "CAREGIVER WAS FILLING P200 TUBE AND GETTING RESIDENT READY FOR BATH WHEN TUB TIPPED FORWARD TO THE RIGHT. SOME WATER WAS EMPTIED, AND TUB FELL BACK TO GROUND. NO ONE WAS INJURED. RESIDENT AND CAREGIVER WERE TO THE LEFT OF TUB."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYSTEM 2000 | BATH SYSTEMS | ILJ | ARJO HOSPITAL EQUIPMENT AB | AP33212-US |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |