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

Model Number M3535A

Device Problems Material Separation (1562); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/04/2023

Event Type  malfunction  

Event Description

It was reported to philips that the smart pads iii did not adhere during testing.There was no patient involvement.

Manufacturer Narrative

Related cases from this customer: (b)(4): reported patient burn.(b)(4): 1st report of pads not adhering; this was during a ¿code¿ ¿ serious injury.(b)(4): 2nd report of pads not adhering; no code reported ¿ product problem.(b)(4): 3rd report of pads not adhering; no code reported ¿ product problem.(b)(4): 4th report of pads not adhering during testing/rca conducted by customer ¿ product problem.Additional details have been requested.

Manufacturer Narrative

His report is based on information provided by manager clinical engineering and philips sales representative has been investigated by the philips complaint handling team.The customer provided the following information.The testing was completed on a manikin energy selected 150j delivered 150j, when pads lot 221005-4034 were removed from the manikin after discharging it was noted that the gel had slight bubbling/separation, before the pads were applied the gel looked normal.Lot number 220921-4032 was noted that the pad adhesive did not feel as sticky as it should be, energy selected was equal to energy delivered on the manikin.Based on the information available and the testing conducted, the issue was related to the pads.The reported problem was confirmed.The engineer provided their analysis findings that the device passes all testing and was put back into service.It is not possible to confirm or determine the cause of failure.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.H3 other text : the customer provided the information.

Manufacturer Narrative

Correction: this report addresses only one lot number which is 221005-4034.This report is based on information provided by manager clinical engineering and philips sales representative has been investigated by the philips complaint handling team.The customer provided the following information.The testing was completed on a manikin energy selected 150j delivered 150j, when pads lot 221005-4034 were removed from the manikin after discharging it was noted that the gel had slight bubbling/separation, before the pads were applied the gel looked normal.Based on the information available and the testing conducted, the issue was related to the pads.The reported problem was confirmed.The engineer provided their analysis findings that the device passes all testing and was put back into service.It is not possible to confirm or determine the cause of failure.The investigation concludes that no further action is required at this time.If additional information is received the complaint file will be reopened.The customer provided the information.

• 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: tanya deschmidt ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 16301947
• MDR Text Key: 308865225
• Report Number: 3030677-2023-00517
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,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 Number: M3535A
• Device Catalogue Number: M3535A
• Device Lot Number: 221005-4034
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/06/2023
• Initial Date FDA Received: 02/05/2023
• Supplement Dates Manufacturer Received: 01/06/2023; 01/06/2023
• Supplement Dates FDA Received: 12/14/2023; 12/18/2023
• Was Device Evaluated by Manufacturer?: No
• 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