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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 Problems Failure To Run On AC/DC (1001); Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 04/26/2018
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, a biomedical engineer contacted physio-control to report that their device would not remain powered on.The user reported that the they found both batteries in the device to be fully depleted.The device was connected to an ac power adapter to charge the batteries.After being charged, one battery displayed three bars; however each time the device was powered on, it would power itself back off.This occurred multiple times.The biomed took the device to their shop for further evaluation.The biomed observed that intermittently the device was either unable to complete a boot cycle or would power on briefly for a few seconds then power itself off.During the testing, one battery displayed three bars and the other battery was depleted, and the device was connected to the same ac power adapter used by the end user.The batteries were charged overnight, and the next morning the device was able to be powered on ten times without any issues.There device was not used with a patient during the reported event.
 
Event Description
The customer, a biomedical engineer contacted physio-control to report that their device would not remain powered on.The user reported that the they found both batteries in the device to be fully depleted.The device was connected to an ac power adapter to charge the batteries.After being charged, one battery displayed three bars; however each time the device was powered on, it would power itself back off.This occurred multiple times.The biomed took the device to their shop for further evaluation.The biomed observed that intermittently the device was either unable to complete a boot cycle or would power on briefly for a few seconds then power itself off.During the testing, one battery displayed three bars and the other battery was depleted, and the device was connected to the same ac power adapter used by the end user.The batteries were charged overnight, and the next morning the device was able to be powered on ten times without any issues.There device was not used with a patient during the reported event.
 
Manufacturer Narrative
Physio-control evaluated the customer¿s device and verified the reported issue.Physio reviewed the downloaded the device¿s electronic records and it was observed that the ac power adapter was not transmitting data to the device.The cause of the reported issue was determined to be the ac power adapter and extension cables.An x-ray confirmed that there was damage in the extension cable.After observing proper device operation through functional and performance testing, the device was returned to the customer for use.The customer has purchased replacement cables.
 
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Brand Name
LIFEPAK(R) 15 MONITOR/DEFIBRILLATOR
Type of Device
AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)
Manufacturer (Section D)
PHYSIO-CONTROL, INC. - 3015876
11811 willows road ne
redmond WA 98052
MDR Report Key7527512
MDR Text Key108729126
Report Number0003015876-2018-00798
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K142430
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 07/31/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/18/2018
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number15
Device Catalogue Number99577-001258
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/08/2018
Date Manufacturer Received07/24/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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