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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 Problem Moisture or Humidity Problem (2986)
Patient Problem Insufficient Information (4580)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2021.Date of report: 01feb2021.
 
Event Description
The customer reported a resonance had occurred.There was no patient involvement.The manufacturer¿s international service technician confirmed the reported issue.The vibration dampening ring which was attached to the rubber boots connecting a blower and an air outlet port generated resonance with vibration in the blower.The manufacturer¿s international service technician readjusted the vibration dampening ring to address the reported problem.The unit successfully passed the required performance verification test.
 
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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 Key11264086
MDR Text Key230976379
Report Number2031642-2021-00385
Device Sequence Number1
Product Code MNT
UDI-Device Identifier00884838033832
UDI-Public(01)00884838033832
Combination Product (y/n)N
PMA/PMN Number
K082660
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial
Report Date 01/06/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberV60
Device Catalogue Number1076709
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received01/06/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/03/2020
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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