MASTERSCREEN BODY MS-BODY/DIFF SES 30336-001

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-01-03 for MASTERSCREEN BODY MS-BODY/DIFF SES 30336-001 manufactured by Carefusion, Inc.

Event Text Entries

[63803175] (b)(4). A carefusion field service representative (fsr) went onsite to evaluate the device. The fsr determined that the device had a defective demand valve and the component was replaced. After the repair, the demand valve was not available for return to the manufacturer. At this time, the customer has not responded to requests for additional information regarding this event. If additional information becomes available, it will be submitted in a follow up report.
Patient Sequence No: 1, Text Type: N, H10


[63803176] The customer reported while performing a lung diffusion carbon monoxide (dlco) test the demand valve is continuously blowing during the patient's efforts and the patient complained, "it hurt her lungs". There was no further information regarding patient harm or injury with the reported issue, it is currently unknown.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2021710-2017-05167
MDR Report Key6220679
Date Received2017-01-03
Date of Report2017-01-03
Date of Event2016-12-05
Date Mfgr Received2016-12-05
Device Manufacturer Date2016-04-01
Date Added to Maude2017-01-03
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJILL RITTORNO
Manufacturer Street22745 SAVI RANCH PARKWAY
Manufacturer CityYORBA LINDA CA 92887
Manufacturer CountryUS
Manufacturer Postal92887
Manufacturer G1CAREFUSION, INC
Manufacturer StreetLIEBNIZSTRASSE 7
Manufacturer CityHOECHBERG
Manufacturer CountryGM
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameMASTERSCREEN BODY
Generic NamePLETHYSMOGRAPH, VOLUME
Product CodeJEH
Date Received2017-01-03
Model NumberMS-BODY/DIFF SES
Catalog Number30336-001
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION, INC
Manufacturer AddressLIEBNIZSTRASSE 7 HOECHBERG GM


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-01-03

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