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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 Defective Alarm (1014); Energy Output Problem (1431)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2021.Date of report: 26feb2021.
 
Event Description
The customer reported error codes saying blower stalled when the device was powered on.The errors were check vent: blower stalled or blower not running at required speeds, check vent: backup alarm failed, and check vent: aux alarm supply failed.There was no patient involvement.The customer spoke with a remote service engineer (rse) and confirmed.The errors were check vent: blower stalled or blower not running at required speeds, check vent: backup alarm failed, check vent: aux alarm supply failed, and check vent: 35 v supply failed in the error log.The rse advised to swap out the power management board or motor controller board to help diagnose the problem.The customer swapped the power management board and the issue was resolved.The customer requested onsite service for repair.
 
Manufacturer Narrative
The philips field service engineer (fse) replaced the power management (pm) printed circuit board assembly (pcba) which was replaced as part of field change order service.The unit was functionally tested and successfully passed all testing.The unit was returned to service.No other anomaly was reported.
 
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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
Manufacturer (Section G)
RICA
2271 cosmos court
carlsbad CA 92011
Manufacturer Contact
yobana sanchez
2271 cosmos court
carlsbad, CA 92011
9093746996
MDR Report Key11389290
MDR Text Key242348515
Report Number2031642-2021-00755
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/09/2022
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 Model NumberV60
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/29/2021
Initial Date FDA Received02/26/2021
Supplement Dates Manufacturer Received08/08/2022
Supplement Dates FDA Received08/09/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/28/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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