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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 Failure to Discharge (1169)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/25/2022
Event Type  malfunction  
Manufacturer Narrative
Reporting institution phone: (b)(6).Reporter phone: (b)(6).
 
Event Description
It was reported to philips that the internal paddles are damaged / broken.The customer worked with the technical support representative.The customer confirmed the damaged paddles.The device needs internal paddles.Upon conclusion of the evaluation, it was determined that this was a malfunction of the internal paddles, the replacement for which was ordered to customer.The customer to install paddles.The device remains at the customer site and no further evaluation is warranted at this time.
 
Manufacturer Narrative
(b)(6).
 
Event Description
It was reported to philips that the internal paddles are damaged / broken.The customer worked with the technical support representative.The customer confirmed the damaged paddles.The device needs internal paddles.Upon conclusion of the evaluation, it was determined that this was a malfunction of the internal paddles, the replacement for which was ordered to customer.The customer to install paddles.The device remains at the customer site and no further evaluation is warranted at this time.
 
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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
olympia betonio
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key13579415
MDR Text Key285955063
Report Number3030677-2022-01142
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838023680
UDI-Public00884838023680
Combination Product (y/n)N
Reporter Country CodeSP
PMA/PMN Number
K110825
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
1 Device was Involved in the Event
1 Patient was Involved in the Event
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
Initial Date Manufacturer Received 01/25/2022
Initial Date FDA Received02/22/2022
Was Device Evaluated by Manufacturer? Yes
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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