FDA Adverse Event
Other
Summary report: N
CONCERTO, BASIC & SHOWER TROLLEY
MDR report key: 1698696
·
Received May 19, 2010
Report
- Report Number
- 9611530-2010-00023
- Event Type
- Other
- Date Received
- May 19, 2010
- Date of Event
- March 30, 2010
- Report Date
- April 13, 2010
- Manufacturer
- ARJO HOSPITAL EQUIPMENT AB
- Product Code
- FSA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INCIDENTS INVOLVING MEDICAL DEVICES MANUFACTURED BY ARJO (B)(4) WILL BE REPORTED BY US, THE LEGAL MFR, ARJO (B)(4) ON BEHALF OF OUR SALES AND DISTRIBUTION COMPANY IN (B)(4), ARJO (B)(4). ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION. (B)(4).
Description of Event or Problem · 1
AS STATED BY THE CUSTOMER 2010 (B)(6): DURING TOILET, THE SIDE SUPPORT IS OPEN AND THE PT FELL. THERE IS NO MAINTENANCE ON THIS SHOWER TROLLEY. CORROSION OF SIDE SUPPORT. TECH INTERVENED ON (B)(6).
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 | BAB1101-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 53 YR |