FDA Adverse Event Malfunction Summary report: N

SYSTEM 2000

MDR report key: 3201518 · Received June 27, 2013

Report

Report Number
9611530-2013-00068
Event Type
Malfunction
Date Received
June 27, 2013
Report Date
June 26, 2013
Manufacturer
ARJO HOSPITAL EQUIPMENT AB
Product Code
ILM
Report Source
Manufacturer report

Narratives

Additional Manufacturer Narrative · 1

THE REPORT IS BEING SUBMITTED UNDER EXEMPTION (B)(4) BY THE MFR ARJO HOSPITAL EQUIPMENT (B)(4) ON BEHALF OF THE IMPORTER (B)(4). ADD'L INFO WILL BE PROVIDED UPON CONCLUSION OF THE MFR'S INVESTIGATION.

Description of Event or Problem · 1

(B)(4).

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
294337 SYSTEM 2000 ILM ARJO HOSPITAL EQUIPMENT AB

Patients

Seq Age Sex Outcome Treatment
1