FDA Adverse Event
Malfunction
Summary report: N
CENTURY (AHE, 50XR & 60XR)
MDR report key: 1971717
·
Received January 13, 2011
Report
- Report Number
- 9611530-2011-00002
- Event Type
- Malfunction
- Date Received
- January 13, 2011
- Date of Event
- December 23, 2010
- Report Date
- December 29, 2010
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- ILJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- 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 MFR, ARJO HOSPITAL EQUIPMENT AB IN (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN THE (B)(4). ADDITIONAL INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.
Description of Event or Problem · 1
AS STATED BY THE CUSTOMER (B)(6) 2010: PER THE AHUS SVC TECH - "CENTURY III WHIRLPOOL TIPPED OVER SPILLING WATER ALL OVER FLOOR." AHUS SVC TECH ALSO STATES THAT A CALYPSO CHAIR WAS INVOLVED (MODEL# CDB7003-01; SN (B)(4)). (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CENTURY (AHE, 50XR & 60XR) | BATH, SITZ, POWERED | ILJ | ARJO HOSPITAL EQUIPMENT AB | AK62611-US |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR |