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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 QUIK-COMBO ELECTRODES WITH REDI-PAK PRE-CONNECT SYSTEM; ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION
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PHYSIO-CONTROL, INC. - 3015876 QUIK-COMBO ELECTRODES WITH REDI-PAK PRE-CONNECT SYSTEM; ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION Back to Search Results
Catalog Number 11996-000017
Device Problem Device Sensing Problem (2917)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/01/2018
Event Type  malfunction  
Manufacturer Narrative
(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.
 
Event Description
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.
 
Manufacturer Narrative
The defibrillation electrodes were forwarded to our failure analysis center, however they were not received properly and were considered lost in the shipment process.Therefore, further investigation was not possible and a cause of the reported issue could not be determined.
 
Event Description
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.
 
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Brand Name
QUIK-COMBO ELECTRODES WITH REDI-PAK PRE-CONNECT SYSTEM
Type of Device
ELECTRODE, ELECTRODCARDIOGRAPH, MULTI-FUNCTION
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key8120987
MDR Text Key129042833
Report Number0003015876-2018-02016
Device Sequence Number1
Product Code MLN
Combination Product (y/n)N
PMA/PMN Number
K960329
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Type of Report Initial,Followup
Report Date 06/12/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/30/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number11996-000017
Device Lot Number823217
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/27/2018
Date Manufacturer Received05/22/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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