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

Model Number M3535A

Device Problems Crack (1135); Fracture (1260)

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

Event Date 01/10/2024

Event Type  malfunction  

Event Description

It was reported to philips that the device had fallen to the ground and that the power module had a broken case as a result.There was no patient involvement.

Manufacturer Narrative

Philips received a complaint on the heartstart mrx indicating that the defibrillator has slight dents.The device was not in clinical use at the time the issue was discovered.The complaint investigation revealed that the defibrillator fell to the ground, resulting in slight dents, but the device still passed the functional test.Based on the available information and the conducted testing, the cause of the reported problem was likely that the defibrillator falling to the ground and sustaining damage occurred due to its lack of mechanical attachment to the cart it was placed on, possibly as a result of the cart's fast movement.The defibrillator still passed the functional test despite the slight dents.The investigation concludes that no further action is required at this time.

• 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: 18565654
• MDR Text Key: 333506031
• Report Number: 3030677-2024-00319
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838000018
• UDI-Public: 00884838000018
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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
• 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?: No
• Initial Date Manufacturer Received: 01/10/2024
• Initial Date FDA Received: 01/23/2024
• Supplement Dates Manufacturer Received: 02/21/2024
• Supplement Dates FDA Received: 01/24/2024
• 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