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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL PALMTOP VENTILATOR, MODELS PTV-8, PTV-10; VENTILATOR, CONTINUOUS, FACILITY USE
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VYAIRE MEDICAL PALMTOP VENTILATOR, MODELS PTV-8, PTV-10; VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
Model Number ENVE VENTILATOR
Medical Device Problem Code Mechanical Problem (1384)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 07/06/2020
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
The equipment was received in vyaire facility for evaluation and the service technician was unable to verify the reported circuit test failed problem.The technician performed the circuit leak test 50 times at multiple angles with 9.6lpm and passed.
 
Event or Problem Description
The customer reported to vyaire medical that the enve ventilator failed on a patient.They took it off the patient and power it up again and the circuit test failed.The ventilator was removed from the patient and the customer confirmed that there was no patient harm associated with the reported event.
 
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Brand Name
PALMTOP VENTILATOR, MODELS PTV-8, PTV-10
Common Device Name
VENTILATOR, CONTINUOUS, FACILITY USE
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa, il
MDR Report Key10485778
Report Number2031702-2020-03643
Device Sequence Number19619005
Product Code CBK
UDI-Device Identifier00845873000005
UDI-Public(01)00845873000005
Combination Product (Y/N)N
Initial Reporter CountryUS
PMA/510(K) Number
K070594
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source health professional,user faci
Initial Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date (Section B) 07/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberENVE VENTILATOR
Device Catalogue Number19250-001-99
Was Device Available for Evaluation? Yes
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 07/06/2020
Initial Report FDA Received Date09/02/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
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