Avalon Patient ModuleRecalls & reported problems
Philips Medizin Systeme Böblingen GmbH · Avalon Patient Module · Class 2
- Adverse event reports
- 3
- Deaths reported
- 1
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00884838012141), received between Oct 19, 2021 and Feb 4, 2026 — classified as 1 death, 2 malfunctions.
The most frequently reported specific device problem is “Incorrect Measurement” (3 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Incorrect Measurement3
- Incorrect, Inadequate or Imprecise Result or Readings1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
- Insufficient Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2026Incorrect Measurement; Incorrect, Inadequate or Imprecise Result or Readings
PHILIPS RECEIVED A COMPLAINT ON AN AVALON PATIENT MODULE INDICATING THAT THE DEVICE WAS NOT READING CORRECTLY. THE DEVICE WAS IN USE ON A PATIENT AT TIME OF EVENT, THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24256711 ↗DeathJun 18, 2024Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED FETAL MONITORING WAS DIFFICULT AND THERE WAS A LOSS OF SIGNAL DURING EPIDURAL INSERTION, REQUIRING PLACEMENT OF A FETAL SCALP ELECTRODE. ONCE IN PLACE, THE MONITOR GENERATED A COINCIDENCE ALARM FOR 20 MINUTES BETWEEN THE FETAL AND MATERNAL HEART RATES. FOLLOWING THE VAGINAL BIRTH, THE BABY WAS BROUGHT TO THE NICU BUT COULD NOT BE RESUSCITATED AND SUBSEQUENTLY PASSING AWAY. THERE WERE NO COMPLICATIONS DURING DELIVERY AND AUTOPSY OF THE BABY WAS PENDING. THE CUSTOMER DID NOT BELIEVE THERE SHOULD HAVE BEEN A COINCIDENCE WHEN USING A FETAL SCALP ELECTRODE. THE ELECTRODE WAS DISCARDED, AND THE MONITORS SEQUESTERED.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 19561343 ↗MalfunctionOct 19, 2021Incorrect Measurement; Incorrect Measurement
IT WAS REPORTED THAT THE AVALON PATIENT MODULE MEASUREMENTS WERE NOT CORRECT. IT IS UNKNOWN IF THE DEVICE WAS IN USE AT TIME OF EVENT. THERE WAS NO ADVERSE EVENT REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12660887 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.