LEVEL 1 EQUATOR BLOWERS
Received May 9, 2023 · Event occurred Nov 1, 2021
Report 3012307300-2023-05412 · MDR key 16897181
Device
Product problems
- Mechanical Problem
- Mechanical Problem
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
D4: UDI IS UNKNOWN. THIS REMEDIATION MDR WAS GENERATED UNDER PROTOCOL B10010116, AS A RESULT OF WARNING LETTER CMS# (B)(4). NO CAUSES OR POTENTIAL CAUSES OF THE CUSTOMER'S REPORTED PROBLEM WERE FOUND DURING THE REVIEW OF SERVICE AND REPAIR RECORDS. A PRODUCT SAMPLE WAS RECEIVED FOR EVALUATION. VISUAL AND FUNCTIONAL TESTING WERE PERFORMED. THE MOTOR DOESN'T WORK EVEN THOUGH IT PASSED THE SELFTEST. AFTER REPLACING THE CAPACITOR OF THE MOTOR WITH A KNOWN GOOD ONE FOR TESTING PURPOSES THE DEVICE WORKS BUT HITS ON THE HOUSING, ESPECIALLY ON THE FRONT / STEP SWITCH AND THERMISTOR HOSE CABLE CONNECTION AREA, CHANGES THE REAL TEMPERATURE RAPIDLY.THE ROOT CAUSE OF THE REPORTED ISSUE WAS FOUND TO BE A POSSIBLE FAULTY MAINBOARD. ACTIONS WERE TAKEN TO MITIGATE THE REPORTED ISSUE: REPLACED THE SINGLE PHASE MOTOR, MOTOR MOUNT PLATE ,SHAFT SLEEVE, RETAINING RING, IMPELLER 27 VANE, RECEPTACLE CABLE, CONTROL BOARD AND STEP / MEMBRANE SWITCH.
Description of Event or Problem
IT WAS REPORTED THERE WAS AN OVERHEATING FROM DEVICE ENGINE. NO PATIENT INJURY WAS REPORTED.