CARESCAPE B450 MBA313Recalls & reported problems
GE Healthcare Finland Oy · CARESCAPE B450 MBA313 · Class 2
All models of CARESCAPE B450 (2)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00840682142380), received between Aug 22, 2025 and Aug 22, 2025 — classified as 1 injury.
The most frequently reported specific device problem is “Data Problem” (1 report).
1 FDA recall record name this device's identifier, 1 still open.
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.
Reports received per month
Recalls naming this device
- Sep 26, 2025Open, Classified
Potential loss of monitoring on affected monitors when powered by certain batteries. Affected batteries can lose capability to hold charge and provide back up power. If this situation occurs, it will cause loss of patient monitoring and potentially delay recognizing patient status changes requiring treatment.
Z-0453-2026 · Root cause: Component change control · Recall details · FDA record ↗
Most reported problems
Device problems
- Data Problem1
- Improper or Incorrect Procedure or Method1
Patient problems
- Insufficient Information1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryAug 22, 2025Improper or Incorrect Procedure or Method; Data Problem; Improper or Incorrect Procedure or Method; Data Problem
IT WAS REPORTED THAT A PATIENT'S MONITORING DATA WAS INADVERTENTLY COMBINED WITH ANOTHER PATIENT. THE PATIENT WAS MISDIAGNOSED AND WAS UNNECESSARILY TREATED WITH MEDICATION. THE PATIENT DID NOT SUSTAIN ANY INJURY DUE TO THE UNNECESSARY TREATMENT.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 22872117 ↗
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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 · each recall links to the FDA recall notice
- 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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