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

Catalog Number CON-EQ-5000HF-115V

Device Problems Overheating of Device (1437); Failure to Shut Off (2939)

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

Event Type  malfunction  

Event Description

It was reported that the device is over temping and not shutting off.No patient injury was reported.Additional information was requested; however, no further information was received.

Manufacturer Narrative

A product sample was received and is awaiting evaluation and investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.Udi section is unknown, no product information has been provided to date.

Manufacturer Narrative

Other, other text: h6: event problem and evaluation codes: updated.H10: device evaluation: the device was returned for investigation.A visual inspection and functional test were performed.Visual inspection found the device presented with wear and tear damaged top and bottom enclosures.The customer stated problem was not duplicated.No device problem was found.No action was taken due to the age and condition of the device.It was deemed beyond economical repair and was scrapped.The cause of the reported problem could not be determined.A dhr (device history review) was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer reported problem were found during the review of service and repair records.

• Brand Name: LEVEL 1 EQUATOR CONVECTIVE WARMER
• Type of Device: SYSTEM, THERMAL REGULATING
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15260064
• MDR Text Key: 305266641
• Report Number: 3012307300-2022-15693
• Device Sequence Number: 1
• Product Code: DWJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CON-EQ-5000HF-115V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2022
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1