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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC. PHILIPS RESPIRONICS V60; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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RESPIRONICS CALIFORNIA, INC. PHILIPS RESPIRONICS V60; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE Back to Search Results
Model Number V60
Device Problems No Display/Image (1183); Loss of Power (1475); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Hypoxia (1918); Low Oxygen Saturation (2477); Increased Respiratory Rate (2486)
Event Date 09/08/2021
Event Type  Injury  
Event Description
A covid positive patient was on continuous bipap and the machine went black and shut off, with the error "vent inoperable, 1009" across the black screen.The patient began to desaturate to the 40's.The rn removed the bipap and placed the patient on high flow nasal cannula and non-rebreather.Despite supplemental oxygen and replacement of bipap the patient continued to be hypoxic with o2 sat 80's and tachypneic to 40's.The patient was ultimately intubated due to concern for acute decompensation without adequate recovery.The bipap machine has been pulled from service and an ticket was placed with clinical engineering.
 
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Brand Name
PHILIPS RESPIRONICS V60
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC.
2271 cosmos ct
carlsbad CA 92011
MDR Report Key12494770
MDR Text Key272127726
Report Number12494770
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Type of Report Initial
Report Date 09/10/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberV60
Device Catalogue Number1053617
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/10/2021
Event Location Hospital
Date Report to Manufacturer09/20/2021
Initial Date Manufacturer Received Not provided
Initial Date FDA Received09/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age18980 DA
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