MAUDE Adverse Event Report: PHILIPS NORTH AMERICA LLC HEARTSTART MRX -EMS DEFIBRILLATOR

Model Number M3536A

Device Problem Failure to Charge (1085)

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

Event Date 08/25/2021

Event Type  malfunction  

Event Description

It was reported that the device's indicator shows not charging when placed on the monitor.There was reportedly no patient involvement.

Event Description

It was reported that the device's indicator shows not charging when placed on the monitor.There was reportedly no patient involvement.The manufacturer's authorized field service engineer (fse) evaluated the device and confirmed the reported problem.Problem description by engineer : customer function/role: device use: expected and unexpected results: user impact: patient impact: current software version: diagnostic performed by engineer : we confirmed the customer's report.Equipment has a faulty battery and another with pending calibration.The battery with calibration request was calibrated and waits the customer's information of the calibration result.After attempting to calibrate the other battery we found it is malfunctioning and has to be replaced.Batteries 0620-063-p rev e; 16218-1066-p rev n; waiting for new batteries.Emergency care & resuscitation procedure: 1 - lp cd notice was delivered to the customer.2 -we found no field change orders open for this equipment) ".Follow up required: replacement of batteries and testing of the equipment.Upon conclusion of the evaluation, it was determined that this was a malfunction of the battery, the replacement for which was ordered.The device remains at the customer site and no further evaluation is warranted at this time.

• Brand Name: HEARTSTART MRX -EMS DEFIBRILLATOR
• 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: dana tackett ; 22100 bothell everett highway; bothell, WA 98021 ; 9095703538
• MDR Report Key: 12475223
• MDR Text Key: 271500316
• Report Number: 3030677-2021-14310
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838006652
• UDI-Public: 00884838006652
• Combination Product (y/n): N
• Reporter Country Code: PO
• 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

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3536A
• Device Catalogue Number: M3536A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2006
• 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