FDA Adverse Event
Malfunction
Summary report: N
CARENDO
MDR report key: 1930390
·
Received October 6, 2010
Report
- Report Number
- 9611530-2010-00072
- Event Type
- Malfunction
- Date Received
- October 6, 2010
- Date of Event
- September 7, 2010
- Report Date
- September 29, 2010
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- 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 INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
BASED UPON VERY LIMITED INFORMATION RECEIVED, IT IS ALLEGED THE LEFT ARM OF A CARENDO CHAIR DETACHED WHILST IN USE. NO OTHER INFORMATION HAS BEEN MADE AVAILABLE AT TIME OF REPORTING. (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | CARENDO | LIFT, PATIENT, NON-AC-POWERED | FSA | ARJO HOSPITAL EQUIPMENT AB | BIB2004-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |