INOMAX DSIR PLUS (DELIVERY SYSTEM) 10007

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2020-01-31 for INOMAX DSIR PLUS (DELIVERY SYSTEM) 10007 manufactured by Mallinckrodt Manufacturing Llc..

Event Text Entries

[181789243] Reportable malfunction with inomax dsir plus (b)(4) was documented and investigated under (b)(4). A review of the device's service log revealed that a delivery stopped alarm occurred as the monitored no value (i. E. , actual: 113 ppm) was greater than the absolute max of 100 ppm for 12 consecutive seconds. Afterwards, a service log entry for failed low no cell calibration due to the low points being greater than the maximum value (max: 655 counts; actual value: 906 counts) was observed. Although identified in the service log, the regional service center (rsc) did not experience a delivery stopped alarm during testing. The root cause for this occurrence was likely due to a malfunctioning no sensor. As a result, the device's no sensor was replaced. Trends were reviewed for this reportable condition and determined to be within the established control limits. No further action is required at this time. A full functional test was performed and the device operated according to specifications. As a result, the device was placed back into circulation for customer use.
Patient Sequence No: 1, Text Type: N, H10


[181789244] On (b)(6) 2019, a customer from the us called to report delivery stopped,failed no sensor, and sample line / filter block,high no - condition with inomax dsir plus (b)(4). Inomax dsir plus (b)(4) was removed from service and returned to the company for service evaluation. On 01-jan-2020, an internal employee performed a routine service log review for inomax dsir plus (b)(4) and discovered a delivery stopped alarm due to no greater than absolute max of 100 ppm followed by a failed low no cell calibration. This service log finding meets the criteria of a reportable malfunction.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number3004531588-2020-00009
MDR Report Key9656085
Report SourceCOMPANY REPRESENTATIVE
Date Received2020-01-31
Date of Report2020-01-31
Date of Event2019-11-25
Date Mfgr Received2020-01-01
Device Manufacturer Date2016-12-20
Date Added to Maude2020-01-31
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 ContactMS. MEGAN VERNAK
Manufacturer Street1425 US ROUTE 206
Manufacturer CityBEDMINSTER NJ 07921
Manufacturer CountryUS
Manufacturer Postal07921
Manufacturer Phone9082386455
Manufacturer G1MALLINCKRODT MANUFACTURING LLC.
Manufacturer Street6603 FEMRITE DRIVE
Manufacturer CityMADISON WI 53718
Manufacturer CountryUS
Manufacturer Postal Code53718
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameINOMAX DSIR PLUS (DELIVERY SYSTEM)
Generic NameAPPARATUS
Product CodeMRN
Date Received2020-01-31
Returned To Mfg2019-12-13
Model Number10007
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerMALLINCKRODT MANUFACTURING LLC.
Manufacturer Address6603 FEMRITE DRIVE MADISON WI 53718 US 53718


Patients

Patient NumberTreatmentOutcomeDate
10 2020-01-31

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