FDA Adverse Event Malfunction Summary report: N

MAXI MOVE

MDR report key: 3251910 · Received July 22, 2013

Report

Report Number
9611530-2013-00087
Event Type
Malfunction
Date Received
July 22, 2013
Manufacturer
ARJO HOSPITAL EQUIPMENT AB
Product Code
FSA
Report Source
Manufacturer report

Narratives

Additional Manufacturer Narrative · 1

THE REPORT IS BEING SUBMITTED UNDER EXEMPTION (B)(4) BY THE MFR ARJO (B)(4) ON BEHALF OF THE IMPORTER (B)(4). THE WAS INSPECTED ON-SITE BY A REP OF THE MFR'S SALES AND SVC UNIT SUBSIDIARY DIV, NOT A DIRECT EMPLOYEE OF THE MFR. ADD'L INFO WILL BE PROVIDED UPON COMPLETION OF THE MFR'S INVESTIGATION.

Description of Event or Problem · 1

(B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
340579 MAXI MOVE FSA ARJO HOSPITAL EQUIPMENT AB

Patients

Seq Age Sex Outcome Treatment
1