NA 82-6881Recalls & reported problems
Medos International Sàrl · Patient Monitor Interface Cable - Philips (12 pin) · Class 2
Data updated Oct 16, 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 10886704075714), received between Feb 21, 2023 and Feb 21, 2023 — 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 16, 2026.
Most reported problems
Device problems
- Incorrect, Inadequate or Imprecise Result or Readings1
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.
MalfunctionFeb 21, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings
LINKED TO MFG REPORT NUMBERS: 3013886523-2022-00538, 3013886523-2022-00539, 3013886523-2022-00540, 3013886523-2022-00541 AND 3013886523-2022-00542. A FACILITY REPORTED THE ICP READINGS OF A MICROSENSOR WERE STABLE 2-3 HOURS AFTER IMPLANTATION. BUT AFTER THAT, THE VALUE KEPT DRIFTING DOWN UNTIL IT WAS IN THE NEGATIVE RANGE AT SOME POINT. 4 CERELINK ICP SENSOR WITH METAL SKULL PIN SET WERE IMPLANTED, 2 DIFFERENT DIRECTLINK MODULES WERE USED. ALL CABLES WERE SWAPPED AND DIFFERENT PATIENT MONITORS CONNECTED. THE ERROR KEPT APPEARING. ACCORDING TO REPORTED INFORMATION, IT IS UNKNOWN IF THERE WAS PATIENT INJURY AND IT IS ALSO UNKNOWN IF THERE WAS SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 16409553 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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