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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 Result or Readings (1535); Device Displays Incorrect Message (2591)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2020.Date of report: 09mar2020.
 
Event Description
It was reported that the unit's "breaths per minute" was not correct.The device was in use at the time of the event; however, there was no patient harm.The manufacturer's field service engineer (fse) performed troubleshooting and was unable to confirm the reported issue.The fse did note that the unit declared a low leak co2 rebreathing risk error.When the fse inspected the unit's blower assembly and gas delivery system (gds), there was an unknown yellow liquid inside.The fse replaced the gds and blower assembly and the issue was resolved.
 
Manufacturer Narrative
G4: 25jul2020.B4: 28jul2020.Gas delivery system (gds) assembly and blower motor (blower motor assembly) were returned for analysis.Visual inspection revealed the revealed no anomalies.Failure investigation (fi) technician installed the gds assembly into a fi ventilator to duplicate the reported issue.During the unit testing the air flow sensor failed, the reported issue was duplicated, and the fi technician identified that a component in reference designation u1 on the air flow sensor out of specification.There was no fault was found with the blower unit.Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.
 
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Brand Name
V60 VENTILATOR
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, INC
2271 cosmos court
carlsbad CA 92011
MDR Report Key9809152
MDR Text Key190369644
Report Number2031642-2020-00854
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
PMA/PMN Number
K082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Type of Report Initial,Followup
Report Date 02/21/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberV60
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2020
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 02/21/2020
Initial Date FDA Received03/09/2020
Supplement Dates Manufacturer Received02/21/2020
Supplement Dates FDA Received07/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER
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