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

Catalog Number 37000

Device Problem Electromagnetic Compatibility Problem (2927)

Patient Problem Oversedation (1990)

Event Date 10/02/2023

Event Type  Injury  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 327078183
• Report Number: 2110898-2023-00097
• Device Sequence Number: 1
• Product Code: FLL
• UDI-Device Identifier: 00608223370001
• UDI-Public: 00608223370001
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120412
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: 37000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2023
• Initial Date FDA Received: 11/01/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Sex: Male