FDA Adverse Event
Malfunction
Summary report: N
CONCERTO, BASIC & SHOWER TROLLEY
MDR report key: 2020149
·
Received March 8, 2011
Report
- Report Number
- 9611530-2011-00023
- Event Type
- Malfunction
- Date Received
- March 8, 2011
- Date of Event
- February 25, 2011
- Report Date
- March 3, 2011
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- 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 THE (B)(4). ADDITIONAL INFORMATION WILL BE PROVIDED UPON CONCLUSION OF THE MANUFACTURER'S INVESTIGATION.
Description of Event or Problem · 1
AS STATED BY THE CUSTOMER 2011-(B)(6): PATIENT HAS BEEN TRANSFERRED ON CONCERTO FROM HER BED. WHEN THE PATIENT WAS ON THE CONCERTO, THE STRETCHER HAS BEEN TILTED ON THE SIDE (ITSELF). THE PATIENT HAS SLID AND SHE FELL ON THE FLOOR. MANUFACTURER'S REF. NO (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 | BAB1000-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |