MAUDE Adverse Event Report: SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD TD60 TELEMETRY TRANSMITTER

Model Number	TD60 TELEMETRY TRANSMITTER
Medical Device Problem Code	Device Alarm System (1012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/13/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Mindray field service representative collected system logs and ecg strips for investigation.The td60 was misplaced by the user and will not available for physical evaluation.The investigation is ongoing.
Event or Problem Description
No product malfunction was reported.It was reported that on (b)(6) 2025, at 20:15, the patient in room (b)(6), connected to the td60 telemetry monitor (id tele 22), was experiencing rhythm changes and multiple pvcs.The patient was also reported to be off tele 45 minutes to an hour before asystole.The patient expired.
Event or Problem Description
No product malfunction was reported.It was reported that on (b)(6) 2025, at 20:15, the patient in room (b)(6), connected to the td60 telemetry monitor (id tele 22), was experiencing rhythm changes and multiple pvcs.The patient was also reported to be off tele 45 minutes to an hour before asystole.The patient expired.
Additional Manufacturer Narrative
The mindray field service representative collected system logs and ecg strips for investigation.The td60 was misplaced by the user and was not available for physical evaluation.The user facility confirmed that the time of patient disconnection was 19:13:58, and the time of patient death was approximately 21:46.Log analysis shows that during the incident, the device issued appropriate alarms, and the dms generated expected sounds.The benevision dms in use with td60 performed per specifications; no product malfunction occurred.

• Brand Name: TD60 TELEMETRY TRANSMITTER
• Common Device Name: TD60
• Manufacturer (Section D): SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD; 1203 nanhuan avenue; guangming district; shenzhen, guangming 51810 6; CH 518106
• Manufacturer Contact: sonia vale ; 800 macarthur blvd.; mahwah, NJ 07430 ; 2019958643
• MDR Report Key: 21327495
• Report Number: 3009156722-2025-00003
• Device Sequence Number: 15485850
• Product Code: MSX
• UDI-Device Identifier: 06944904093413
• UDI-Public: 06944904093413
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K220058
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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: TD60 TELEMETRY TRANSMITTER
• Device Catalogue Number: 115-047566-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/15/2025
• Supplement Date Received by Manufacturer: 02/21/2025
• Initial Report FDA Received Date: 02/06/2025
• Supplement Report FDA Received Date: 03/20/2025
• Was Device Evaluated by Manufacturer? (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: Death
• Patient Age: 31 YR
• Patient Sex: Female
• Patient Weight: 92 KG