CARESCAPE R860Recalls & reported problems
Datex-Ohmeda Inc · CARESCAPE R860 · Class 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.
Quick summary
This Datex-Ohmeda CARESCAPE R860 is a facility-use ventilator. Its 4,378 adverse event reports mostly describe insufficient flow, failure to run on battery and other power problems. The reports include 1 death and 17 injuries. 1 recall names this device: started in April 2022 and still open, it covers a battery backup that is too weak, so the ventilator can shut down early when not plugged into mains power.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 4,346
- Deaths reported
- 1
- Injuries reported
- 17
- Recalls naming it
- 1
Summary
The FDA's MAUDE database contains 4,346 adverse event reports that list this exact device (DI 00840682102346), received between Jan 30, 2018 and Sep 30, 2026 — classified as 1 death, 17 injuries, 4,327 malfunctions.
The most frequently reported specific device problem is “Insufficient Flow or Under Infusion” (1,914 reports).
1 FDA recall record name this device's identifier, 1 still open.
5 other recalls cover devices cleared under the same FDA submission (K142679, K210384); they may or may not involve this specific model.
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
- Apr 18, 2022Open, Classified
Insufficient battery backup power resulting in premature shutdown of the ventilator when not connected to AC mains power supply.
Z-1226-2022 · Root cause: Under Investigation by firm · Recall details · FDA record ↗
Most reported problems
Device problems
- Insufficient Flow or Under Infusion1,914
- Failure to Run on Battery1,098
- Power Problem340
- Mechanical Problem292
- Therapeutic or Diagnostic Output Failure142
- No Apparent Adverse Event119
- Unexpected Therapeutic Results106
- Failure to Power Up95
Patient problems
- No Clinical Signs, Symptoms or Conditions4,311
- Low Oxygen Saturation16
- No Patient Involvement12
- Capsular Contracture2
- Cardiac Arrest2
- No Consequences Or Impact To Patient2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Muscle Hypotonia1
Recent adverse event reports
The 25 most recent of 4,346 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Failure to Run on Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952203 ↗MalfunctionSep 30, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50952183 ↗MalfunctionSep 30, 2026Measurement System Incompatibility
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50951867 ↗MalfunctionSep 30, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949732 ↗MalfunctionSep 30, 2026Failure to Power Up
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949635 ↗MalfunctionSep 30, 2026Insufficient Flow or Under Infusion
It was reported that there was a malfunction resulting in insufficient O2 during pre-use checkout. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50946828 ↗MalfunctionSep 30, 2026Failure to Run on Battery
It was reported that there was a battery failure during pre-use checkout that could cause loss of mechanical ventilation. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945593 ↗MalfunctionSep 30, 2026Mechanical Problem
It was reported that there was a malfunction during pre-use checkout resulting in loss of ventilation.There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945540 ↗MalfunctionSep 30, 2026Failure to Run on Battery
It was reported that there was a battery failure that could cause loss of mechanical ventilation during pre-use checkout. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944267 ↗MalfunctionSep 30, 2026Failure to Run on Battery
It was reported that there was a battery failure that could cause loss of mechanical ventilation during pre-use checkout. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50944102 ↗MalfunctionSep 29, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50940951 ↗MalfunctionSep 29, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50936810 ↗MalfunctionSep 29, 2026Insufficient Flow or Under Infusion
It was reported that there was a malfunction resulting in insufficient O2 during planned maintenance. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934340 ↗MalfunctionSep 29, 2026Failure to Run on Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934124 ↗MalfunctionSep 29, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50934123 ↗MalfunctionSep 29, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50933099 ↗MalfunctionSep 29, 2026Insufficient Flow or Under Infusion
It was reported that there was a malfunction resulting in insufficient O2 during pre-use checkout. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932972 ↗MalfunctionSep 29, 2026Failure to Run on Battery
It was reported that there was a battery failure that could cause loss of mechanical ventilation during pre-use checkout. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50932797 ↗MalfunctionSep 29, 2026Failure to Run on Battery
It was reported that there was a battery failure during pre-use checkout that could cause loss of mechanical ventilation. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930553 ↗MalfunctionSep 29, 2026Failure to Run on Battery
It was reported that there was a battery failure during pre-use checkout that could cause loss of mechanical ventilation. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930552 ↗MalfunctionSep 29, 2026Failure to Run on Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50930547 ↗MalfunctionSep 28, 2026Failure to Run on Battery
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926665 ↗MalfunctionSep 28, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50926509 ↗MalfunctionSep 28, 2026Insufficient Flow or Under Infusion
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917928 ↗MalfunctionSep 28, 2026Improper Flow or Infusion
It was reported that there was a malfunction resulting in insufficient O2. There was no patient involvement.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917871 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K142679, K210384. One submission often covers many models, so check the product and lot details in each record.
- Z-1227-2022 · Apr 18, 2022 · Open, ClassifiedReplacement back up batteries distributed on or after April 1, 2019, for CARESCAPE R860, Engstrom Carestation and Engstrom PRO Ventilators.
- Z-2883-2020 · Jul 14, 2020 · TerminatedCARESCAPE R860 Ventilator The CARESCAPE R860 ventilator is a microprocessor based, electronically controlled, pneumatically driven ventilator that includes integrated monitoring o
- Z-0463-2019 · Oct 5, 2018 · TerminatedGE HEALTHCARE CARESCAPE R860 Inspiratory Safety Guard, Part Numbers: a) 2066713-001 (single pack) b) 2083208-001 (box of ten singles) The CARESCAPE R860 ventilator is designed to
- Z-2738-2018 · Jun 28, 2018 · TerminatedThe Neonatal Flow Sensor Cable used on devices CARESCAPE R860, ENGSTROM CARESTATION, ENGSTROM PRO and contained in Neonatal Software Upgrade Kit 2080496-010. The CARESCAPE R860 v
- Z-2266-2018 · Dec 8, 2017 · TerminatedCARESCAPE R860 ventilators with software version 10SP05 Product Usage: The CARESCAPE R860 ventilator is designed to provide mechanical ventilation or support to neonatal, pediatri
Other VENTILATOR, CONTINUOUS, FACILITY USE devices
- Trilogy Trilogy100 Ventilator, United StatesRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE92 deaths8,161 reports
- Trilogy Evo Trilogy Evo, USARespironics, Inc. · Ventilator, continuous, facility use6 recalls50 deaths4,393 reports
- Trilogy 100 Trilogy 100 W/ Bluetooth, USARespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE65 deaths4,569 reports
- HAMILTON-C1 161001Hamilton Medical AG · Ventilator, Continuous, Facility Use2 recalls12 deaths1,849 reports
- Trilogy Trilogy O2 Ventilator JapanRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE7 deaths1,900 reports
- Trilogy Trilogy 202 Ventilator InternationalRespironics, Inc. · VENTILATOR, CONTINUOUS, FACILITY USE11 deaths1,564 reports
- HAMILTON-C6 160021Hamilton Medical AG · Ventilator, Continuous, Facility Use5 recalls10 deaths1,175 reports
- Vela 16600Carefusion Corporation · Ventilator, Continuous, Facility Use4 deaths1,225 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 · 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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