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U.S. Department of Health and Human Services

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

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PHILIPS NORTH AMERICA LLC HEARTSTART MRX MONITOR/DEFIB; DEFIBRILLATOR Back to Search Results
Model Number M3535A
Device Problem Failure to Read Input Signal (1581)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/07/2021
Event Type  malfunction  
Event Description
While servicing the device, an authorized bench technician discovered that the device was not recognizing the therapy cable.There was no patient involvement.
 
Event Description
While servicing the device, an authorized bench technician discovered that the device was not recognizing the therapy cable.The customer requested that the device be returned for bench repair.The device was received by the bench repair service on 30-jun-2021.Upon evaluation of the device by an authorized bench technician, it was discovered that the unit failed to recognize an installed therapy cable due to a faulty therapy pca.Based on the conclusion of the evaluation, it was determined that this was a malfunction of the therapy pca.The therapy pca was replaced and the device was deemed fit for use.Following the repair, the unit was returned to the customer to be placed back into service.There is no indication of a systemic problem.No further investigation or action is warranted.
 
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Brand Name
HEARTSTART MRX MONITOR/DEFIB
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
elizabeth proctor
22100 bothell everett highway
bothell, WA 98021
9095703538
MDR Report Key12258930
MDR Text Key264489533
Report Number3030677-2021-13315
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838000018
UDI-Public00884838000018
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K031187
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type 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? Device Returned to Manufacturer
Date Returned to Manufacturer06/30/2021
Is the Reporter a Health Professional? Yes
Distributor Facility Aware Date07/07/2021
Initial Date Manufacturer Received 07/07/2021
Initial Date FDA Received08/02/2021
Supplement Dates Manufacturer Received07/07/2021
Supplement Dates FDA Received01/12/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/22/2008
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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