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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART XL+ DEFIBRILLATOR/MONITOR

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PHILIPS NORTH AMERICA LLC HEARTSTART XL+ DEFIBRILLATOR/MONITOR Back to Search Results
Model Number 861290
Device Problem Intermittent Loss of Power (4016)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/22/2021
Event Type  malfunction  
Event Description
It was reported to philips that the device has intermittent boot up errors.There was no patient involvement.
 
Manufacturer Narrative
Complaint evaluation: the field service engineer (fse) evaluated the device and found option keys missing.The business unit being contacted for keys information.Customer resolution and conclusion: upon conclusion of the evaluation, it was determined that the device needed the option keys.The option keys were updated and the device is normal and ready for use.
 
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Brand Name
HEARTSTART XL+ DEFIBRILLATOR/MONITOR
Type of Device
DEFIBRILLATOR
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
dana tackett
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key12331992
MDR Text Key266904294
Report Number3030677-2021-13669
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838023680
UDI-Public00884838023680
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K110825
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/17/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number861290
Device Catalogue Number861290
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date07/22/2021
Date Manufacturer Received07/23/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/06/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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