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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HS1 DEFIBRILLATOR, DUTCH, EXCHANGE AED

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PHILIPS NORTH AMERICA LLC HS1 DEFIBRILLATOR, DUTCH, EXCHANGE AED Back to Search Results
Model Number M5066A
Device Problem No Audible Prompt/Feedback (2282)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It has been reported that the device is failing self-test.
 
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Brand NameHS1 DEFIBRILLATOR, DUTCH, EXCHANGE
Type of DeviceAED
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 Key11975550
MDR Text Key255403038
Report Number3030677-2021-12123
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeNL
PMA/PMN Number
P160029
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign
Reporter Occupation
Type of Report Initial,Followup,Followup
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model NumberM5066A
Device Catalogue Number453564428301
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/16/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Distributor Facility Aware Date06/04/2021
Event Location No Information
Date Manufacturer Received09/29/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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