MalfunctionKLA
WATER PERFUSION MANOMETRY
Received Jun 4, 2015 · Event occurred Jun 1, 2015
Report MW5043025 · MDR key 4834873
Device
Product problems
- Device Reprocessing Problem
Patient
0 MO
- No Information
Narrative
Description of Event or Problem
ARMDORFER AND MMS WATER PERFUSION MANOMETRY SYSTEM HAS INADEQUATE CLEANING INSTRUCTIONS. THESE DEVICES WERE MANUFACTURED PRIOR TO 1976 AND THE CLEANING INSTRUCTIONS DO NOT HOLD UP TO TODAYS STANDARDS. THESE UNITS ARE STILL IN USE THROUGHOUT MANY HOSPITALS.