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

Model Number M3535A

Device Problem Failure to Discharge (1169)

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

Event Date 03/15/2022

Event Type  malfunction  

Manufacturer Narrative

Reporter's phone number: (b)(6).

Event Description

It was reported to philips that the device has a possible failure of the therapy selection button.The alleged failure was observed while the device was in clinical use, however, no adverse patient impact was reported by the customer.

Manufacturer Narrative

A good faith effort was made to obtain additional information associated with this complaint evaluation, but attempts have been unsuccessful.If additional information is later obtained, the complaint will be reopened.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 : a good faith effort was made to obtain additional information regarding customer resolution associated with this complaint, but attempts have been unsuccessful.

Event Description

It was reported to philips that the device has a possible failure of the therapy selection button.The alleged failure was observed while the device was in use on a patient, however, no adverse patient impact was reported by the customer.

• Brand Name: HEARTSTART MRX MONITOR/DEFIB
• Type of Device: DEFIBRILATOR
• 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: ruby jean vergara ; 22100 bothell everett highway; ste a; bothell, WA 98021 ; 9095703538
• MDR Report Key: 14058936
• MDR Text Key: 288983290
• Report Number: 3030677-2022-01696
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• Combination Product (y/n): N
• Reporter Country Code: BR
• 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
• Report Date: 03/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/15/2022
• 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