MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY 001-372500

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2017-09-28 for MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY 001-372500 manufactured by Vyaire Medical, Inc.

Event Text Entries

[87849393] (b)(4). A vyaire field service representative (fsr) went onsite to evaluate the device. The fsr determined that the box calibration could not be performed. Constant 'close door' error message appears and a burning smell was noticed. He localized the issue to the interface card where an ic chip on the card began to melt. A replacement card was installed and the device meets all factory specifications. If additional information becomes available, it will be submitted in a follow up report.
Patient Sequence No: 1, Text Type: N, H10


[87849394] The customer reported the impulse oscillometer (ios) that is connected to the system is getting general initialization failed, ios not found. It is unknown if there was any patient impact or harm associated with the event.
Patient Sequence No: 1, Text Type: D, B5


[113691200] At the time of the initial submission the failure investigation report was not included. Results of investigation: the vyaire failure analysis laboratory received the system box however no investigation could be performed due to the part being returned improperly packaged, without a cover or an electro-static discharge bag, compromising the functionality of the pcbas.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2021710-2017-06718
MDR Report Key6902880
Report SourceHEALTH PROFESSIONAL,USER FACI
Date Received2017-09-28
Date of Report2018-01-08
Date of Event2017-07-17
Date Mfgr Received2018-01-08
Device Manufacturer Date2003-08-01
Date Added to Maude2017-09-28
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactKRISTIN GRAF
Manufacturer Street22745 SAVI RANCH PARKWAY
Manufacturer CityYORBA LINDA CA 92887
Manufacturer CountryUS
Manufacturer Postal92887
Manufacturer G1VYAIRE MEDICAL, INC
Manufacturer StreetLEIBNIZSTRASSE 7
Manufacturer CityHOECHBERG
Manufacturer CountryGM
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameMASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY
Generic NamePLETHYSMOGRAPH, VOLUME
Product CodeJEH
Date Received2017-09-28
Returned To Mfg2017-09-06
Catalog Number001-372500
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerVYAIRE MEDICAL, INC
Manufacturer AddressLEIBNIZSTRASSE 7 HOECHBERG US


Patients

Patient NumberTreatmentOutcomeDate
10 2017-09-28

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