• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) 20 DEFIBRILLATOR/MONITOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number 20
Device Problem Device Inoperable (1663)
Patient Problem No Patient Involvement (2645)
Event Date 05/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Physio-control evaluated the customer's device but was unable to duplicate the reported issue. Physio then completed unrelated repairs and after observing proper device operation through functional and performance testing the unit was returned to the customer for use. The cause of the reported issue could not be determined.
 
Event Description
The customer contacted physio-control to report that their device would not complete the boot-up cycle in order to power on. As a result, defibrillation would not be possible if it were necessary. The customer further advised that the device appeared to have been dropped because it had exterior physical damage. The customer advised that the device was found at the nurses station in this condition and they were unsure when the actual damage occurred. Based on the information available, physio-control could not determine if the reported issue was the result of the physical damage observed by the customer or a device malfunction.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameLIFEPAK(R) 20 DEFIBRILLATOR/MONITOR
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
megan marseglia
11811 willows road ne
redmond, WA 98052
4258674000
MDR Report Key7606381
MDR Text Key111308511
Report Number0003015876-2018-00940
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K130454
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial
Report Date 06/15/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number20
Device Catalogue Number99402-000033
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/30/2018
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/22/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/19/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

-
-