Telemetry Transmitter(TD60 with Resp) 115-047566-00Recalls & reported problems
Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 2
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 06944904093413), received between Feb 6, 2025 and Feb 6, 2025 — classified as 2 deaths.
The most frequently reported specific device problem is “Device Alarm System” (2 reports).
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Reports received per month
Most reported problems
Device problems
- Device Alarm System2
Patient problems
- Insufficient Information2
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
DeathFeb 6, 2025Device Alarm System; Device Alarm System
NO PRODUCT MALFUNCTION WAS REPORTED. IT WAS REPORTED THAT ON (B)(6), 2025, AT 20:15, THE PATIENT IN ROOM 432, 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.
Patient problems: Insufficient Information
MAUDE report 21327496 ↗DeathFeb 6, 2025Device Alarm System; Device Alarm System
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.
Patient problems: Insufficient Information
MAUDE report 21327495 ↗
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- CNS-2101 Central MonitorNihon Kohden Corporation · System, Network And Communication, Physiological Monitors3 deaths76 reports
- BeneVision Central Monitoring SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd. · System, Network And Communication, Physiological Monitors1 recall2 deaths5 reports
- eCareManager 4.5Visicu, Inc. · System, network and communication, physiological monitors1 recall1 death1 report
- eCareManager 4.6Visicu, Inc. · System, network and communication, physiological monitors1 recall0 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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