MAUDE Adverse Event Report: 3M HEALTH CARE 3M¿ SPOTON¿ TEMPERATURE MONITORING SYSTEM 37000

Catalog Number	37000
Medical Device Problem Code	Electromagnetic Compatibility Problem (2927)
Health Effect - Clinical Code	Oversedation (1990)
Date of Event	10/02/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
A 3m representative reported on behalf of the customer upon removing the 3m¿ spoton¿ temperature monitoring system 37000 sensor cable, the sed line indicated a deeper level of anesthesia than when the temperature monitoring cable was applied alleging interference.An unspecified dosage of narcan was provided to the patient due to higher level of administered anesthesia.No further interventions were reported for the patient.
Additional Manufacturer Narrative
The device has not been returned to 3m for analysis.Per the instruction for use (ifu), it provides device compatibility specifications.The 3m¿ spoton¿ temperature monitoring system 37000 was tested in accordance with and conforms to both iec 60601-1 - medical electrical equipment - part 1: general requirements for basic safety and essential performance and iec 60601-1-2 medical electrical equipment - part 1-2: general requirements for basic safety and essential performance - collateral standard: electromagnetic disturbances.3m will continue to monitor.

• Brand Name: 3M¿ SPOTON¿ TEMPERATURE MONITORING SYSTEM 37000
• Common Device Name: SPOTON¿
• Manufacturer (Section D): 3M HEALTH CARE; 2510 conway ave; st. paul MN 55144 1000
• Manufacturer (Section G): 3M COMPANY EDEN PRAIRIE; 10351 west 70th street; 10351 west 70th street MN 53344
• Manufacturer Contact: nadia battah ; 3m center, building 275-5w-06; 2510 conway ave; st. paul, MN 55144 ; 6514612670
• MDR Report Key: 18048117
• Report Number: 2110898-2023-00097
• Device Sequence Number: 15472922
• Product Code: FLL
• UDI-Device Identifier: 00608223370001
• UDI-Public: 00608223370001
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K120412
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 37000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2023
• Initial Report FDA Received Date: 11/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male