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

Model Number M3535A

Device Problems Device Alarm System (1012); Protective Measures Problem (3015)

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

Event Date 08/03/2023

Event Type  malfunction  

Manufacturer Narrative

Philips is in the process of obtaining additional information concerning this event and the complaint is still under investigation.A final report will be submitted once the investigation is complete.

Event Description

It was reported the device has red cross and blinking.The device was reported to be in use, however, no direct adverse event to the patient or user was reported.

Manufacturer Narrative

This report is based on information provided by a philips field service engineer (fse) and has been reviewed by the philips complaint handling team.The reported issue initially described a device displaying a red cross and blinking.In an attempt to resolve the problem, the fse provided remote assistance to the user, who followed the provided steps.However, the issue persisted despite these efforts.Subsequently, the fse visited the location in person and examined the device, ultimately identifying that the problem stemmed from the incorrect placement of a paddle.After repositioning the paddle to its original position and conducting operational checks, the device was successfully restored to full functionality.In summary, the device's red cross and blinking problem was effectively resolved on-site by addressing the mis-positioned paddle, initially overlooked during the remote troubleshooting process.Based on the available information and the conducted testing, the cause of the reported problem was determined to be an incorrect placement of the paddle.The reported problem has been confirmed.Based on the information available and results of additional analysis, no further action is necessary at this time.The resolution involved the fse repositioning the incorrectly placed paddle to its original position, followed by operational checks, which successfully restored the device to full functionality.It has been concluded that no further action is required at this time.If additional information is received, the complaint file will be reopened.

• 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: 17643971
• MDR Text Key: 322202043
• Report Number: 3030677-2023-03413
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• 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 Number: M3535A
• Device Catalogue Number: M3535A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2023
• Initial Date FDA Received: 08/29/2023
• Supplement Dates Manufacturer Received: 08/03/2023
• Supplement Dates FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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