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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX MONITOR/DEFIB; DEFIBRILATOR

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PHILIPS NORTH AMERICA LLC HEARTSTART MRX MONITOR/DEFIB; DEFIBRILATOR Back to Search Results
Model Number M3535A
Device Problem Failure to Discharge (1169)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/10/2022
Event Type  malfunction  
Event Description
It was reported to philips that the external paddles produced a spark when using.The alleged failure was observed while the device was in clinical use, however, no adverse patient impact was reported by the customer.
 
Manufacturer Narrative
The customer requested that a philips field service engineer (fse) be dispatched to the customer site.The reported issue was confirmed and traced to a charred paddle plate.Upon conclusion of the evaluation, it was determined that this was a malfunction of the paddle plate.The paddle plate was replaced to resolve the reported issue.The device remains at the customer site and no further evaluation is required at this time.
 
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Brand Name
HEARTSTART MRX MONITOR/DEFIB
Type of Device
DEFIBRILATOR
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
daniel derochers
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key13977217
MDR Text Key288380294
Report Number3030677-2022-01695
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838000018
UDI-Public00884838000018
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K031187
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
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberM3535A
Device Catalogue NumberM3535A
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 03/10/2022
Initial Date FDA Received04/01/2022
Supplement Dates Manufacturer Received03/10/2022
Supplement Dates FDA Received04/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2015
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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