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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 11/05/2022
Event Type  malfunction  
Event Description
Philips received a complaint from customer reporting low tidal volume on a v60 ventilator during a self test.The device was not in clinical use.There was no report of harm.A philips authorized service provider (asp) reported the customer biomed repaired the gds (gas delivery system).The device was operational after repairs were completed.The customer did not provide other requested information.The investigation concludes that no further action is required at this time.
 
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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 Key15931969
MDR Text Key305997652
Report Number2031642-2022-03060
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,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2022
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? Yes
Date Manufacturer Received11/23/2022
Was Device Evaluated by Manufacturer? No
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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