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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS HEALTHCARE RESPIRONICS PHILIPS V60 VENTILATOR; V60 VENTILATOR

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PHILIPS HEALTHCARE RESPIRONICS PHILIPS V60 VENTILATOR; V60 VENTILATOR Back to Search Results
Model Number 850008
Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Volume Accuracy Problem (1675)
Patient Problems Bradycardia (1751); Low Oxygen Saturation (2477)
Event Date 04/07/2020
Event Type  Death  
Event Description
Bipap ventilator (v60) used at intubation of covid positive pt.After intubation and hooked up to ventilator, pt became bradycardic and had low oxygen saturation.Machine noted to be functioning.Concern for return volume on screen was not correct.Device returned to mfr.Per maintenance reports from phillips on the ventilator involved in the event, the unit had preventative maintenance completed on 03/27/2020.It had no hours logged since meaning that the vent was used for a short period of time.Phillips performed testing on the unit and it had no hard failures.
 
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Brand Name
PHILIPS V60 VENTILATOR
Type of Device
V60 VENTILATOR
Manufacturer (Section D)
PHILIPS HEALTHCARE RESPIRONICS
MDR Report Key10005755
MDR Text Key189214184
Report Number10005755
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Physician
Type of Report Initial
Report Date 04/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number850008
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/21/2020
Distributor Facility Aware Date04/08/2020
Event Location Hospital
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age45 YR
Patient Weight136
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