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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 15
Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 08/24/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 device logged event codes and displayed abnormal energy delivery message. Customer advised that back up device was available and was used to continue with patient care. The patient associated with the event was not harmed. Patient is male, about (b)(6) years old.
 
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Brand NameLIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
Type of DeviceAUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
Manufacturer (Section G)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
Manufacturer Contact
todd bandy
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key9082767
MDR Text Key174611099
Report Number0003015876-2019-01555
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
P160026
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 01/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/18/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number15
Device Catalogue Number99577-001505
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/30/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/06/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/08/2019
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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