FDA Adverse Event
Malfunction
Summary report: N
CONCERTO, BASIC & SHOWER TROLLEY
MDR report key: 1993129
·
Received January 20, 2011
Report
- Report Number
- 9611530-2011-00005
- Event Type
- Malfunction
- Date Received
- January 20, 2011
- Date of Event
- December 17, 2010
- Report Date
- January 14, 2011
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
WE ARE REPORTING ACCORDING TO EXEMPTION NO (B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO HOSPITAL EQUIPMENT AB IN (B)(4) WILL BE REPORTED BY US, THE LEGAL MANUFACTURER, ARJO HOSPITAL EQUIPMENT AB IN (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN (B)(4). ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
AS STATED BY THE CUSTOMER 2011-(B)(6): CLIENT WAS SHOWERED, STRAIGHT UP AS USUAL. SHE GOT AN EPILEPTIC ATTACK IN THE SHOWER. SHE FELL TO THE RIGHT. THE CARER TRIED TO STOP HER BUT SHE WAS WET SO NOT STOPPABLE. CARER ENDED ON THE FLOOR WITH CLIENT ON TOP. DEVICE HAS BEEN CHECKED ON (B)(4) 2011, ALL FUNCTIONS CONFORM PRODUCT SPECIFICATIONS. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CONCERTO, BASIC & SHOWER TROLLEY | LIFT, PATIENT, NON-AC-POWERED | FSA | ARJO HOSPITAL EQUIPMENT AB | BAB1107-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 42 YR |