MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC PROBE GENERAL PURPOSE 12F; THERMOMETER, ELECTRONIC, CLINICAL

Catalog Number	ER400-12
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/28/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device exhibited inaccurate temperatures.There was patient involvement and no adverse event/patient harm reported.
Additional Manufacturer Narrative
Investigation summary: the effected device was not returned.There were no pictures available for review.Without the return of the used samples, a comprehensive failure investigation cannot be performed, and a probable cause cannot be determined.

• Brand Name: PROBE GENERAL PURPOSE 12F
• Common Device Name: THERMOMETER, ELECTRONIC, CLINICAL
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC; 6000 nathan lane n; minneapolis MN 55442
• Manufacturer Contact: reed covert ; 6000nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 19651238
• Report Number: 3012307300-2024-05673
• Device Sequence Number: 15073890
• Product Code: FLL
• UDI-Device Identifier: 30695085000451
• UDI-Public: (01)30695085000451(17)270314(10)4458957
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K863646
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: ER400-12
• Device Lot Number: 4458957
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/15/2024
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown