MAUDE Adverse Event Report: ST PAUL LEVEL 1 EQUATOR BLOWERS; SYSTEM, THERMAL REGULATING

Catalog Number EQ-5000-FR-230V

Device Problem Mechanical Problem (1384)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/01/2021

Event Type  malfunction  

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.

Event Description

It was reported there was an overheating from device engine.No patient injury was reported.

• Brand Name: LEVEL 1 EQUATOR BLOWERS
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16897181
• MDR Text Key: 314849594
• Report Number: 3012307300-2023-05412
• Device Sequence Number: 1
• Product Code: DWL
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K181699
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: EQ-5000-FR-230V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1