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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) CR2 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE)

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PHYSIO-CONTROL, INC. - 3015876 LIFEPAK(R) CR2 DEFIBRILLATOR AUTOMATED EXTERNAL DEFIBRILLATORS (NON-WEARABLE) Back to Search Results
Model Number CR2
Device Problems No Audible Prompt/Feedback (2282); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/15/2020
Event Type  malfunction  
Manufacturer Narrative
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. Catalog # of the initial medwatch report indicated: unk_smp. Catalog # of the initial medwatch report should indicate: 99512-000091.
 
Event Description
A customer contacted physio-control to report that their device would not provide audio voice prompts. Without voice prompts, a lay user would not receive the audible instructions on how to properly use the device on a patient which could delay therapy. There was no patient use associated with the reported event.
 
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Brand NameLIFEPAK(R) CR2 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 Key10639376
MDR Text Key210204860
Report Number0003015876-2020-01451
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
P170018
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/06/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCR2
Device Catalogue NumberUNK_SMP
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/20/2020
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/21/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/15/2017
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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