FDA Adverse Event Malfunction Summary report: N

MAXI MOVE

MDR report key: 3221094 · Received July 5, 2013

Report

Report Number
9611530-2013-00072
Event Type
Malfunction
Date Received
July 5, 2013
Manufacturer
ARJO HOSPITAL EQUIPMENT AB
Product Code
FSA
Report Source
Manufacturer report

Narratives

Additional Manufacturer Narrative · 1

THIS REPORT IS BEING FILED UNDER EXEMPTION (B)(4) BY THE MFR, ARJO (B)(4), ON BEHALF OF THE IMPORTER, (B)(4). THE DEVICE WAS INSPECTED ON SITE BY A REP OF THE MFR'S SALES AND SERVICE UNIT SUBSIDIARY DIVISION, NOT A DIRECT EMPLOYEE OF THE MFR. ADDITIONAL INFORMATION WILL BE PROVIDED FOLLOWING THE CONCLUSION OF THE MFR';S INVESTIGATION.

Description of Event or Problem · 1

REF IMP REPORT (B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
307576 MAXI MOVE FSA ARJO HOSPITAL EQUIPMENT AB

Patients

Seq Age Sex Outcome Treatment
1