MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX -EMS DEFIBRILLATOR

Model Number M3536A

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is completed.

Event Description

The customer reported the device would not detect monitored hr (heart rate) from patient with a pacemaker.The device was in use on a patient, however there was no adverse event to the patient or user.

Event Description

The customer reported the device would not detect monitored hr (heart rate) from patient with a pacemaker.The device was in use on a patient, however there was no adverse event to the patient or user.During the event, emergency medical services arrived on scene, and connected the patient to a heartstart mrx via ecg electrodes.Relevant medical history included status post placement of an automated implantable cardioverter defibrillator.No shocks were attempted or delivered during the event.No transcutaneous pacing was attempted or delivered during the event.No adverse event was reported or associated with the use of this device.Electrocardiogram (ecg) rhythm strips and case events file were provided for review.Review of provided electrocardiogram (ecg) rhythm strips and case events showed the heartstart mrx was powered on into monitor mode with patient category set to non-paced at 09:17:13 on (b)(6) 2018.At 00:01 elapsed time (et), ecg leads were placed with lead ii selected as the source ecg.Throughout the entire rhythm strip, the patient had a paced heart rhythm of approximately 80 paced pulses per minute (ppm).The heartstart mrx would calculate the rhythm as an extreme bradycardia.A philips field service engineer (fse) evaluated the device and was unable to duplicate the symptom.There is no information to support that a malfunction occurred.The device was behaving as intended when it would not count the paced pulses as the heart rate.The algorithm counting r waves, not pacer spikes, is an expected device behavior.

• Brand Name: HEARTSTART MRX -EMS DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer (Section G): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021
• Manufacturer Contact: jacqueline nishino ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 8171447
• MDR Text Key: 130619333
• Report Number: 1218950-2018-09799
• Device Sequence Number: 1
• Product Code: MKJ
• 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
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3536A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2014
• 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