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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: VYAIRE MEDICAL MASTERSCREEN; PLETHYSMOGRAPH, PRESSURE
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VYAIRE MEDICAL MASTERSCREEN; PLETHYSMOGRAPH, PRESSURE Back to Search Results
Model Number MASTERSCREEN PAED
Device Problem Electrical /Electronic Property Problem (1198)
Patient Problem No Patient Involvement (2645)
Event Date 07/01/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Any additional information received from the customer will be included in a follow-up report.At this time, the suspect device has not been returned for evaluation.Therefore, root cause has not been determined yet.The replacement for system box and paed controller was already sent to the customer.
 
Event Description
It was reported to vyaire medical that the masterscreen device was found to have a burned circuit board parts inside the system box when they turned on the power during installation.The customer confirmed that there was no patient involvement associated with the reported event.
 
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Brand Name
MASTERSCREEN
Type of Device
PLETHYSMOGRAPH, PRESSURE
Manufacturer (Section D)
VYAIRE MEDICAL
26125 n. riverwoods blvd.
mettawa, il
MDR Report Key10353884
MDR Text Key202055744
Report Number9615102-2020-00114
Device Sequence Number1
Product Code CCM
UDI-Device Identifier04250892900414
UDI-Public(01)04250892900414
Combination Product (y/n)N
PMA/PMN Number
K081823
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Type of Report Initial
Report Date 07/01/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/31/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberMASTERSCREEN PAED
Device Catalogue Number171500
Was Device Available for Evaluation? Yes
Date Manufacturer Received07/01/2020
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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