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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC FRX (W B) DEFIB, US ENGLISH, EXCHG; AED
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PHILIPS NORTH AMERICA LLC FRX (W B) DEFIB, US ENGLISH, EXCHG; AED Back to Search Results
Model Number 861304
Device Problems Failure of Device to Self-Test (2937); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/26/2021
Event Type  malfunction  
Event Description
The user is reporting the device was not able to be used when retrieved for a patient use event.The patient outcome is unknown.
 
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Brand Name
FRX (W B) DEFIB, US ENGLISH, EXCHG
Type of Device
AED
Manufacturer (Section D)
PHILIPS NORTH AMERICA LLC
22100 bothell everett highway
bothell WA 98021
Manufacturer (Section G)
PHILIPS NORTH AMERICA LLC
22100 bothell everett highway
bothell WA 98021
Manufacturer Contact
shannon decker
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key11920555
MDR Text Key253748161
Report Number3030677-2021-11936
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838080768
UDI-Public00884838080768
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
P180028
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number861304
Device Catalogue Number453564595641
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2021
Is the Reporter a Health Professional? No
Distributor Facility Aware Date05/26/2021
Date Manufacturer Received09/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2020
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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