MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX -EMS DEFIBRILLATOR

Model Number M3536A

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/08/2021

Event Type  malfunction  

Event Description

Problem statement it was reported to philips that the device failed to obtain a 12 lead ecg reading when the lead set was re-installed after being unplugged to move a patient.Complaint evaluation the customer requested that an authorized field service engineer (fse) be dispatched to the customer site.An evaluation was performed and the fse was unable to replicate the reported failure.The fse verified that there were no noted issues with the cables, connections or leads associated with the ecg function that could have caused or contributed to the original allegation.The fse reported that they were able to acquire a 12 lead reading and that the unit was fully functional.Customer resolution and conclusion philips is unable to rule out that a malfunction did not occur.As the issue could not be replicated during evaluation, a definitive cause for the alleged failure could not be determined.The device remains at the customer site.There is no indication of a systemic problem.No further investigation or action is warranted.Patient/user involvement was the device being used on a patient at the time of the event, including for the purposes of diagnosis? (yes, no, unknown) yes was there any adverse event to the patient or user? if yes, describe? (yes, no, unknown) no if there was an adverse event, did the device cause or contribute to the adverse event, and how? (answer yes, no, or unknown.If no or unknown, provide explanation including any gfe attempts.) no, there was no reported adverse event to a patient or user as a result of the issue.

• Brand Name: HEARTSTART MRX -EMS DEFIBRILLATOR
• 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: bethany glynn ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 11366807
• MDR Text Key: 233124857
• Report Number: 3030677-2021-10001
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838006652
• UDI-Public: 00884838006652
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• 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 Number: M3536A
• Device Catalogue Number: M3536A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/08/2021
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 02/23/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1