• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, INC V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

RESPIRONICS CALIFORNIA, INC V60 VENTILATOR VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE Back to Search Results
Model Number V60
Device Problems No Audible Alarm (1019); Therapeutic or Diagnostic Output Failure (3023)
Patient Problems Tachycardia (2095); Low Oxygen Saturation (2477)
Event Date 11/28/2020
Event Type  Injury  
Manufacturer Narrative

Date of event: (b)(6) 2020. Date of report: 18dec2020.

 
Event Description

A customer reported to philips that while delivering therapy to a patient, the respironics v60 ventilator stopped delivering breaths to the patient. No alarms were generated, and the patient experienced an event of increased heart rate and decreased oxygen saturation. The customer reported that the unit was in use on a patient at the time of the reported device symptom and adverse event.

 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11038634
MDR Text Key222388284
Report Number2031642-2020-04639
Device Sequence Number1
Product Code MNT
Combination Product (Y/N)N
Reporter Country CodeUS
PMA/PMN NumberK082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type USER FACILITY
Reporter Occupation
Type of Report Initial
Report Date 12/08/2020
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/18/2020
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL NumberV60
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 Received12/08/2020
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured10/17/2014
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: 12/18/2020 Patient Sequence Number: 1
Treatment
UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
-
-