QUIK-COMBO ELECTRODES WITH REDI-PAK PRE-CONNECT SYSTEM 11996-000017

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2018-11-30 for QUIK-COMBO ELECTRODES WITH REDI-PAK PRE-CONNECT SYSTEM 11996-000017 manufactured by Physio-control, Inc. - 3015876.

Event Text Entries

[129042833] (b)(4). Physio-control performed an initial test of the provided defibrillation electrodes and was unable to reproduce the reported issue. Physio-control continues to investigate the reported issue and will submit a supplemental report on this event to the fda as provided by 21 cfr 803. 56.
Patient Sequence No: 1, Text Type: N, H10


[129042834] The customer contacted physio-control to report that their defibrillation electrode did not recognize a patient's ecg when used with either a lifepak 20 defibrillator/monitor or a lifepak 20e defibrillator/monitor. The device showed a dashed line with the defibrillation electrodes connected to the patient. When the electrodes were replaced, the device did recognize the patient's ecg through these new electrodes and functioned properly. There was patient use associated with the reported issue, but no patient information was available.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number0003015876-2018-02016
MDR Report Key8120987
Report SourceFOREIGN
Date Received2018-11-30
Date of Report2018-11-30
Date of Event2018-11-01
Date Mfgr Received2018-11-02
Device Manufacturer Date2018-08-06
Date Added to Maude2018-11-30
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationBIOMEDICAL ENGINEER
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactMR. MEG MARSEGLIA
Manufacturer Street11811 WILLOWS ROAD NE
Manufacturer CityREDMOND WA 98052
Manufacturer CountryUS
Manufacturer Postal98052
Manufacturer Phone4258674000
Manufacturer G1PHYSIO-CONTROL, INC. - 3015876
Manufacturer Street11811 WILLOWS ROAD NE
Manufacturer CityREDMOND WA 98052
Manufacturer CountryUS
Manufacturer Postal Code98052
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameQUIK-COMBO ELECTRODES WITH REDI-PAK PRE-CONNECT SYSTEM
Generic NameELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION
Product CodeMLN
Date Received2018-11-30
Returned To Mfg2018-11-27
Model NumberNA
Catalog Number11996-000017
Lot Number823217
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPHYSIO-CONTROL, INC. - 3015876
Manufacturer Address11811 WILLOWS ROAD NE REDMOND WA 98052 US 98052


Patients

Patient NumberTreatmentOutcomeDate
10 2018-11-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.