NA CBL 5 Lead Snap Chest IEC, ICURecalls & reported problems
Philips Medizin Systeme Böblingen GmbH · 5 Lead Snap Chest IEC, ICU · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00884838010581), received between Mar 26, 2019 and Mar 26, 2019 — classified as 1 malfunction.
The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (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
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 26, 2019Incorrect, Inadequate or Imprecise Result or Readings
THE CUSTOMER STATED THAT THE MRX IS FAILING OPERATIONAL CHECKS DURING THE "LEADS ECG". THE DEVICE WAS IN USE. THERE WAS NO REPORTED PATIENT INCIDENT INJURY.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8451175 ↗
Other CABLE, ELECTRODE devices
- N/A ECG Leadwire set, 5-lead, grouped, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall1 report
- N/A ECG TRUNK CABLE, 6-LEAD, AHA, 1.2 M/4 FTGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 5-lead V2-6, grabber, AHA, 74 cm/ 29 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG TRUNK CABLE, 3-LD W/ INTEGRATED GRABBER LEAD WIRE, IEC, 3.6 M/12 FTGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 3-lead, snap, AHA, 74 cm/ 29 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG TRUNK CABLE, 3/5-LEAD, AHA, 6 M/20 FTGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 5-lead, grabber, AHA, mix 74 cm/ 29 in, 130 cm/ 51 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 recall0 reports
- N/A ECG Leadwire set, 5-lead, grouped, snap, AHA, 74 cm/ 29 inGE Healthcare Finland Oy · CABLE, ELECTRODE1 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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