STATIC AND DYNAMIC COMPLIANCE VMAX ENCORE 229D W/O GAS REG 777401-103

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-03 for STATIC AND DYNAMIC COMPLIANCE VMAX ENCORE 229D W/O GAS REG 777401-103 manufactured by Carefusion, Inc.

Event Text Entries

[51885454] (b)(4). The customer reported the suspect component is available for analysis and an return good authorization (rga) has been issued. At this time, carefusion has not received the suspect component for evaluation.
Patient Sequence No: 1, Text Type: N, H10


[51885455] The company representative reported while using the static and dynamic compliance; the hot wires between pins of the flow sensor were melted. The customer stated the device was not used on a patient for pulmonary function testing at the time of the event.
Patient Sequence No: 1, Text Type: D, B5


[60503201] Results of investigation: the carefusion failure analysis laboratory received the suspect mass flow sensor. Visual examination of the mass flow sensor, as received, revealed the filaments to be burned. The reported "middle hot wire between pins are melted" failure was confirmed. The failure analysis technician determined the root cause to be due to material fatigue. This was noted that this can occur at any time during use whenever the mass flow sensor has reached the end of life. Results of investigation: the carefusion failure analysis laboratory received the suspect mass flow sensor. Visual examination of the mass flow sensor, as received, revealed the filaments to be burned. The reported "middle hot wire between pins are melted" failure was confirmed. The failure analysis technician determined the root cause to be due to material fatigue. This was noted that this can occur at any time during use whenever the mass flow sensor has reached the end of life. Upon further risk assessment, there is no danger of patient harm or user harm at the time of the filament failure as the hot wires are contained inside the plastic sensor housing and do not come in contact with the end user or patient at any time during use. Therefore the initial mdr should have not been submitted. This failure is unlikely to cause harm or injury to a patient or user.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number2021710-2016-04158
MDR Report Key5845462
Date Received2016-08-03
Date of Report2016-11-04
Date of Event2016-07-19
Date Mfgr Received2016-10-07
Device Manufacturer Date2010-05-01
Date Added to Maude2016-08-03
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 ContactJILL RITTORNO
Manufacturer Street22745 SAVI RANCH PARKWAY
Manufacturer CityYORBA LINDA CA 92887
Manufacturer CountryUS
Manufacturer Postal92887
Manufacturer Phone7149227830
Manufacturer G1CAREFUSION, INC
Manufacturer Street1100 BIRD CENTER DR.
Manufacturer CityPALM SPRINGS CA 92262
Manufacturer CountryUS
Manufacturer Postal Code92262
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSTATIC AND DYNAMIC COMPLIANCE
Generic NameCALCULATOR, PREDICTED VALUES, PULMONARY FUNCTION
Product CodeBTY
Date Received2016-08-03
Model NumberVMAX ENCORE 229D W/O GAS REG
Catalog Number777401-103
OperatorHEALTH PROFESSIONAL
Device AvailabilityY
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerCAREFUSION, INC
Manufacturer Address22745 SAVI RANCH PARKWAY YORBA LINDA CA 92887 US 92887


Patients

Patient NumberTreatmentOutcomeDate
10 2016-08-03

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