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  

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.

Event Description

It was reported to philips that the smart pads iii did not adhere to the patient.The nature of use in unclear, however there was no adverse event to the patient or user as a result of the problem.

Manufacturer Narrative

This report is based on information provided by philips representative and has been investigated by the philips complaint handling team.Philips received a complaint about the mrx indicating that the pads were not adhering to the patient.Remote support from the customer care solution center was received by the customer.Multiple attempts were made to request information regarding resolution of the reported problem.No additional information was received this will be documented as a malfunction, the cause of which was not determined.The device remains at the customer site and no further evaluation is warranted at this time.Based on the information available and the testing conducted, the issue was related to the pads.The reported problem was confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.An analysis was performed by a vigilance reporting specialist (vrs).The vrs determined that while no harm was alleged, recurrence of this failure mode during clinical use could cause or contribute to death or serious injury.Therefore, this failure mode meets the definition of a reportable malfunction.Appropriate regulatory reporting actions have been taken.The data entered in this complaint record will be utilized for product quality and safety improvements per the post market surveillance and risk management processes.A good faith effort was made to obtain additional information regarding customer resolution associated with this complaint, but attempts have been unsuccessful.If additional information is later obtained, the complaint will be reopened.H3 other text: remote support from the customer care solution center was received.

• 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: 16301948
• MDR Text Key: 308850636
• Report Number: 3030677-2023-00516
• 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

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: 220921-4032
• 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
• Supplement Dates FDA Received: 12/14/2023
• 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