MAUDE Adverse Event Report: ST PAUL LEVEL 1 ER SERIES PROBES - GENERAL PURPOSE; THERMOMETER, ELECTRONIC, CLINICAL

Model Number	ER400-9
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual and functional testing were performed.The sample was visually inspected at a distance of 12" to 24" in normal conditions of illumination.The failure couldn't be reproduced.The root cause of the reported issue was found to be material in the seal.All mitigations on placed were verified and it was confirmed has been executing according, therefore no corrective actions could be implemented, it will be continue monitoring this failure condition in this product for threshold or escalation.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# (b)(4).
Event or Problem Description
It was reported that before opening the package, the customer confirmed the product and a different product were in the same package.No patient injury or involvement was reported.

• Brand Name: LEVEL 1 ER SERIES PROBES - GENERAL PURPOSE
• Common Device Name: THERMOMETER, ELECTRONIC, CLINICAL
• 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; aichi pref.; minneapolis, MN 55442
• MDR Report Key: 15364267
• Report Number: 3012307300-2022-18015
• Device Sequence Number: 17764063
• Product Code: FLL
• UDI-Device Identifier: 30695085000444
• UDI-Public: 30695085000444
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K863646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/06/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/02/2023
• Device Model Number: ER400-9
• Device Catalogue Number: ER400-9
• Device Lot Number: 24350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/22/2022
• Initial Report FDA Received Date: 09/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown