FDA Adverse Event Malfunction Summary report: N

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MDR report key: 345997 · Received August 8, 2001

Report

Report Number
MW1022579
Event Type
Malfunction
Date Received
August 8, 2001
Report Date
August 1, 2001
Manufacturer
MIELE, INC.
Product Code
MEC
Product Problem
Yes
Report Source
Voluntary report
Reporter Location
PA, US
Reporter Occupation
OTHER

Narratives

Description of Event or Problem · 1

TWO UNITS - ONE UNIT MALFUNCTION DUE TO WIPER ARM OPENING HEATING ELEMENT. OTHER UNIT SHOWED SIGN OF WEAR ON HEATING ELEMENT. REPLACED BOTH ARMS AND INSTALLED RISER GASKET THROUGH RECOMMENDATION BY MFR. CORRECTION OF ABOVE FOR ORIGINALLY MALFUNCTIONED UNIT, GETTING ERROR CODE. FURTHER TROUBLESHOOTING REVEALED A LEAKING SUMP GASKET. TIGHTENING OF CLAMP HAD NO CORRECTIVE EFFECT. DURING BENCH REPAIR, FOUND EXTENSIVE EVIDENCE OF PROLONGED LEAKING ON COMPONENTS. VERY SHORTLY AFTER REPAIR OF ABOVE, SECOND UNIT SUFFERED CATASTROPHIC FAILURE. BENCH REPAIR FOUND EVIDENCE OF EXTENSIVE LEAKING AS WELL. THIS AFFECTED SUMP MOTOR WINDINGS, AND MOST OTHER PARTS WITH REPLACEMENT COST APPROXIMATELY $800. FOUND THE SUMP GASKET RETAINING RING TO BE RELATIVELY LOOSE. SUSPECT RING IS LOOSENING DURING EQUIPMENT OPERATION ALLOWING A PROGRESSIVE INCREASE IN WATER LEAKAGE. CONSTRUCTION OF EQUIPMENT PREVENTS ROUTINE OBSERVATION OF WATER. LITERATURE (WHAT WE'VE BEEN ABLE TO ACQUIRE) IS VERY LIMITING IN VALUE AND DOES NOT REFERENCE A RECOMMENDED PM PROCEDURE. INCREASED ENFORCEMENT BY LOGISTICS PERSONNEL TO FOLLOW INSTRUCTIONS ON LITERATURE REQUIREMENTS. NEED ENFORCEMENT BACKING AT SOME LEVEL IN DEALING WITH A CO NOT IN COMPLIANCE. RECOMMEND THOROUGH INSPECTION AROUND SUMP GASKET FOR EVIDENCE OF WATER LEAKAGE. VERIFY TIGHTNESS OF SECURING RING AROUND SUMP GASKET.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
35835 * DENTAL DISINFECTOR MEC MIELE, INC. C7781 *

Patients

Seq Age Sex Outcome Treatment
1 *