MAUDE Adverse Event Report: TE CONNECTIVITY LTD. 401 PROBE; THERMOMETER, ELECTRONIC, CLINICAL

Model Number 401

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/19/2018

Event Type  malfunction  

Event Description

Had several probes which failed to read, which has jeopardized our ability to monitor individuals' safety and therefore diagnosis any problems.Mfr has refused to acknowledge problem or inspect problem.Failed voltage tests.

• Brand Name: 401 PROBE
• Type of Device: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): TE CONNECTIVITY LTD.
• MDR Report Key: 7714119
• MDR Text Key: 115062837
• Report Number: MW5078537
• Device Sequence Number: 1
• Product Code: FLL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 07/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 401
• Device Catalogue Number: 881101
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1