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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
Device Problems Incorrect, Inadequate or Imprecise Resultor Readings (1535); Noise, Audible (3273)
Patient Problem No Patient Involvement (2645)
Event Type  Malfunction  
Manufacturer Narrative

Date of event: (b)(6) 2020. Report date: 09mar2020.

 
Event Description

It was reported that a noise occurred when the exhalation port was checked and during testing. It was also reported that sometimes the unit failed to go forward to the next step during operation. There was no patient involvement.

 
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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
3000 minuteman road
andover MA 01810
Manufacturer Contact
melissa abbott
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key9808913
MDR Text Key193586823
Report Number2031642-2020-00838
Device Sequence Number1
Product Code MNT
Combination Product (Y/N)N
Reporter Country CodeJA
PMA/PMN NumberK082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/20/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/09/2020
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device MODEL NumberV60
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/20/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured02/02/2017
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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