MR Patient Care Short Standard ECG 2.0 Cable AAMI CAB,4 LD,CV MRI ECGRecalls & reported problems
Philips Ds North America LLC · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838006386), received between Dec 9, 2022 and Dec 9, 2022 — classified as 1 death.
The most frequently reported specific device problem is “No Audible Alarm” (1 report).
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.
Most reported problems
Device problems
- No Audible Alarm1
Patient problems
- Insufficient Information1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
DeathDec 9, 2022No Audible Alarm; No Audible Alarm
THE CUSTOMER REPORTED ECG LEADS OFF ALARM DID NOT CREATE AN AUDIBLE ALARM ON PIIC IX COMPUTER. THE DEVICE WAS IN CLINICAL USE AT THE TIME OF THE REPORTED EVENT. A PATIENT DEATH WAS REPORTED.
Patient problems: Insufficient Information
MAUDE report 15948934 ↗
Other CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR) devices
- IntraSight 797403Philips Image Guided Therapy Corporation · Cable, Transducer And Electrode, Patient, (Including Connector)82 reports
- ASSY, CABLE, ECG, 15 LEAD, 3 WIRE PRECOR 11111Physio-Control, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)1 recall0 reports
- MR Patient Care Short Wide ECG 2.0 Cable AAMI CAB,4 LD,CV MRI ECGPhilips Ds North America LLC · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)12 reports
- NA 5492ALMedtronic, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)10 reports
- NA 5492VLMedtronic, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)10 reports
- NA 5487LMedtronic, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)8 reports
- NA 5487Medtronic, Inc. · CABLE, TRANSDUCER AND ELECTRODE, PATIENT, (INCLUDING CONNECTOR)6 reports
- CORE M2 Vascular System 400-0100.17Volcano Corporation · Cable, Transducer And Electrode, Patient, (Including Connector)6 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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