MAUDE Adverse Event Report: MMS WATER PERFUSION MANOMETRY

Model Number SQ15000805

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Information (3190)

Event Date 06/01/2015

Event Type  malfunction  

Event Description

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.

• Brand Name: WATER PERFUSION MANOMETRY
• Type of Device: WATER PERFUSION MANOMETRY
• Manufacturer (Section D): MMS
• MDR Report Key: 4834873
• MDR Text Key: 5941571
• Report Number: MW5043025
• Device Sequence Number: 1
• Product Code: FFX
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/04/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2015
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/01/2015
• Device Model Number: SQ15000805
• Patient Sequence Number: 1
• Patient Outcome(s): Other