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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 No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
Date of event: (b)(6) 2019.Date of report: 30aug2019.
 
Event Description
The customer reported they are having issues when changing back and forth between non invasive ventilation (niv) and high flow therapy (hft).The customer reported that a significant amount of condensation arises, and that they must dump out the hoses to prevent the patient from regularly getting nasal lavages.The customer asked which hose systems are suitable for both niv and hft.The device was in clinical use at the time the reported issue was discovered; however, there was no reported patient or user harm.
 
Manufacturer Narrative
Date rec¿d by mfr: 01oct2019.Date of repoirt: 01oct2019.This complaint is associated with high flow therapy.High flow therapy is an exported software option and is not available for commercial distribution in the united states.Therefore, the complaint does not fall within fda reporting guidelines.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.
 
Event Description
The customer reported they are having issues when changing back and forth between non invasive ventilation (niv) and high flow therapy (hft).The customer reported that a significant amount of condensation arises, and that they must dump out the hoses to prevent the patient from regularly getting nasal lavages.The customer asked which hose systems are suitable for both niv and hft.The device was in clinical use at the time the reported issue was discovered; however, there was no reported patient or user harm.
 
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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 Key8952312
MDR Text Key156323101
Report Number2031642-2019-07749
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 foreign,user facility
Type of Report Initial,Followup
Report Date 08/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberV60
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received08/16/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
UNKNOWN PATIENT CIRCUIT, MASK, AND HUMIDIFIER.
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