STATIC AND DYNAMIC COMPLIANCE 22D E

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-02-10 for STATIC AND DYNAMIC COMPLIANCE 22D E manufactured by Carefusion.

Event Text Entries

[38490362] This mdr is being submitted in response to a two year retrospective complaint review that was performed by carefusion to identify mdrs following the issuance of a 483. The (b)(4) the device was not returned so no investigation could be done and no root cause could be determined. The device is currently working without issue. If more information becomes available a follow up will be submitted. Carefusion continues to track and trend any incident related to this issue. (b)(4)
Patient Sequence No: 1, Text Type: N, H10


[38490363] The customer reported the isolation transformer started to spark and smell like smoke as if the system was burning. The system was not used after the reported incident. The customer's biomed took a look at the device and determined that the sparking was coming from the wall outlet and not associated with the pulmonary function testing (pft) system. The customer is now using the device without any issues. There was no harm or injury noted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2021710-2016-03158
MDR Report Key5429096
Date Received2016-02-10
Date of Report2013-07-01
Date of Event2013-07-01
Date Mfgr Received2013-07-01
Date Added to Maude2016-02-10
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationRESPIRATORY THERAPIST
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJILL RITTORNO
Manufacturer Street75 NORTH FAIRWAY DRIVE
Manufacturer CityVERNON HILLS IL 60061
Manufacturer CountryUS
Manufacturer Postal60061
Manufacturer Phone8473628056
Manufacturer G1CAREFUSION
Manufacturer Street1100 BIRD CENTER DRIVE
Manufacturer CityPALM SPRINGS CA 92262
Manufacturer CountryUS
Manufacturer Postal Code92262
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameSTATIC AND DYNAMIC COMPLIANCE
Generic NameCALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
Product CodeBTY
Date Received2016-02-10
Model Number22D E
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device Eval'ed by Mfgr*
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION
Manufacturer Address22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887


Patients

Patient NumberTreatmentOutcomeDate
10 2016-02-10

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