MAUDE Adverse Event Report: COVIDIEN AG JUAREZ (MMJ) MON-A-THERM; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 90044

Device Problem Low Readings (2460)

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

Event Date 03/17/2024

Event Type  malfunction  

Manufacturer Narrative

D10: concomitant product: 90044, 90044 400 general purpose sensor 12x50 (lot#20l0429jzx).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

Event Description

According to the reporter, the temperature probe was in place for 48 hours.After removal for intimate washing, reinstallation of the device. malfunction with temperature difference of up to 2 degrees less than the socket tympanic.Changing the probe, using the same reference, the same batch and it had similar problem.There was no patient harm.

• Brand Name: MON-A-THERM
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• Manufacturer (Section G): COVIDIEN AG JUAREZ (MMJ); 1181 hennequen ave.; juarez,chi 32575 ; MX 32575
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19136809
• MDR Text Key: 340572487
• Report Number: 9681384-2024-00011
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 20884521031590
• UDI-Public: 20884521031590
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K874514
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/18/2024

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: 90044
• Device Catalogue Number: 90044
• Device Lot Number: 20L0429JZX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2024
• Initial Date FDA Received: 04/18/2024
• Date Device Manufactured: 12/15/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: PLEASE SEE NOTE ON H11