MAUDE Adverse Event Report: ST PAUL LEVEL 1 EQUATOR BLOWERS

Model Number EQ-5000

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 08/01/2021

Event Type  Injury  

Event Description

It was reported that after the use of the product, the customer noticed the patient got a burn injury.

Manufacturer Narrative

One unit was returned for investigation.Upon physical inspection, it was found that the complained issue could not be duplicated and the device passed all functional tests.A manufacturing dhr review was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.

• Brand Name: LEVEL 1 EQUATOR BLOWERS
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; 2-12-12, kitanagase-omotemachi; minneapolis, MN 55442
• MDR Report Key: 13366695
• MDR Text Key: 284522508
• Report Number: 3012307300-2022-01899
• Device Sequence Number: 1
• Product Code: DWJ
• UDI-Device Identifier: 50695085850005
• UDI-Public: 50695085850005
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K011907
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: EQ-5000
• Device Catalogue Number: EQ-5000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/24/2021
• Initial Date FDA Received: 01/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2019
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1