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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
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RESPIRONICS CALIFORNIA, INC V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE Back to Search Results
Model Number V60 PLUS
Device Problem Therapeutic or Diagnostic Output Failure (3023)
Patient Problem Low Oxygen Saturation (2477)
Event Type  Injury  
Manufacturer Narrative

Event date: (b)(6) 2020. Report date: 16dec2020.

 
Event Description

It was reported that when attempting to change the patient from high flow therapy to continuous positive airway pressure (cpap) the ventilator would not go into standby mode. It was reported that the patient was without oxygen for 2 minutes which resulted in dropping of saturations to 88%. The patient was removed from the ventilator and placed on an alternate ventilator. No patient harm has been reported.

 
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Brand NameV60 VENTILATOR
Type of DeviceVENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC
2271 cosmos court
carlsbad CA 92011
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
carlsbad CA
Manufacturer Contact
bill cole
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key11021437
MDR Text Key221841828
Report Number2031642-2020-04582
Device Sequence Number1
Product Code MNT
Combination Product (Y/N)N
Reporter Country CodeUK
PMA/PMN NumberK102985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type FOREIGN,USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 11/17/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/16/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberV60 PLUS
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/15/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured12/26/2019
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient TREATMENT DATA
Date Received: 12/16/2020 Patient Sequence Number: 1
Treatment
UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
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