MAUDE Adverse Event Report: Sentec AG Sentec; SDM

Model Number	SDM
Medical Device Problem Code	Unintended Electrical Shock (4018)
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	09/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
An incident occurred with sentec sdm device (sn: (b)(6) in which one of the employees of the munich firebrigade (germany) received an electric shock.The device was mounted on a stretcher together with an incubator and other associated equipment.The monitor was to be detached from the stretcher.While doing so, the employee touched the rear of the device and received an electric shock.A minor burn mark was visible on her hand, and both the residual current device (rcd) of the stretcher and the rcd of the station tripped.The device was then disconnected from the mains and taken out of service.
Additional Manufacturer Narrative
The device is currently in transit back to the manufacturer for root cause analysis.

• Brand Name: Sentec
• Common Device Name: SDM
• Manufacturer (Section D): Sentec AG; ringstrasse 39; therwil, baselland 4106 ; SZ 4106
• Manufacturer (Section G): Sentec AG; ringstrasse 39; therwil, baselland 4106 ; SZ 4106
• Manufacturer Contact: oliver friedli ; ringstrasse 39; therwil, baselland 4106 ; SZ 4106
• MDR Report Key: 50927937
• Report Number: 3004149774-2026-00001
• Device Sequence Number: 9525740
• Product Code: LKD
• UDI-Device Identifier: 07640121880018
• UDI-Public: 07640121880018
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151329
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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 Model Number: SDM
• Device Catalogue Number: SDM
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Received by Manufacturer: 09/09/2026
• Initial Report FDA Received Date: 09/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/12/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Sensor OxiVenT (SN: (b)(6).; Service Gas.GAS-0812.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 40 YR
• Patient Sex: Female