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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
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RESPIRONICS CALIFORNIA, LLC RESPIRONICS; VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE Back to Search Results
Model Number V60 VENT, CHINA OPT: CFLEX, AVAPS
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2022
Event Type  malfunction  
Manufacturer Narrative
Reporting address & institution phone #: (b)(6).Reporter phone #: (b)(6).
 
Event Description
It was reported to philips the device prompted low tidal volume.The device was reported to have been in clinical use.There was no patient or user harm.Further information has been requested.If additional information becomes available at a later date, a supplemental report will be submitted.
 
Manufacturer Narrative
E1: reporting address line 1: no.172, gaodili, penglai road, jiangmen city, guangdong province.
 
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Brand Name
RESPIRONICS
Type of Device
VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT, FACILITY USE
Manufacturer (Section D)
RESPIRONICS CALIFORNIA, LLC
2271 cosmos court
carlsbad CA 92011
Manufacturer (Section G)
RESPIRONICS CALIFORNIA, LLC
2271 cosmos court
carlsbad CA 92011
Manufacturer Contact
kimberly shelly
2271 cosmos court
carlsbad, CA 92011
7609187300
MDR Report Key15079639
MDR Text Key296688523
Report Number2031642-2022-01911
Device Sequence Number1
Product Code MNT
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K102985
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberV60 VENT, CHINA OPT: CFLEX, AVAPS
Device Catalogue Number1076716
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Date Manufacturer Received08/02/2022
Date Device Manufactured06/04/2016
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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