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

Model Number M3536A

Device Problem Communication or Transmission Problem (2896)

Patient Problem Cardiac Arrest (1762)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to philips that during an event of cardiac arrest, the heartstart mrx monitor / defibrillator would not recognize the defibrillator pads that were used.Emergency medical services reported that another manufacturer¿s defibrillator pads (conmed) were used, and that the treatment was continued on another device (manufacturer not reported) using the same conmed pads.We are considering this as a serious injury as the event occurred while the device was in use on a patient in cardiac arrest and that the treatment was interrupted requiring the use of another defibrillator.

Event Description

It was reported to philips that during an event of cardiac arrest, the heartstart mrx monitor / defibrillator would not recognize the defibrillator pads that were used.Emergency medical services reported that another manufacturer¿s defibrillator pads (conmed) were used, and that the treatment was continued on another device (manufacturer not reported) using the same conmed pads.We are considering this as a serious injury as the event occurred while the device was in use on a patient in cardiac arrest and that the treatment was interrupted requiring the use of another defibrillator.The reporter stated that a (b)(6) years old male patient weighing approximately (b)(6) pounds, experienced an event of cardiopulmonary arrest, on (b)(6) 2019.During the event, emergency medical service (ems) arrived on scene, initiated cardiopulmonary resuscitation (cpr) rescue efforts, connected the patient to the heartstart mrx device via conmed defibrillator pads; model, lot number, and expiration date not reported, but the device would not recognize that defibrillator pads had been attached.Ems staff then connected the conmed pads to another device; manufacturer and model not reported, and were able to provide treatment to the patient.The outcome of the patient experiencing a cardiopulmonary arrest was not reported.A philips repair bench technician evaluated the device and was unable to duplicate the symptom.No electrocardiogram (ecg) rhythm strips or case events file were provided for review.Use only the multifunction electrode pads (philips brand), and accessories as listed in the instructions for use.Substitutions may cause the heartstart mrx to function improperly.Use multiufunction electrode pads prior to their expiration date.Discard pads after use.Do not reuse pads.Do not use for more than eight hours of continuous pacing (heartstart mrx instructions for use m3535a/m3536a, publication number 453564307761, edition 2, 2012, table 82, pages 295, 296, and 353).The device was behaving as intended when it would not recognize the non-philips brand defibrillator pads.The device not recognizing the conmed defibrillator pads is an expected device behavior where this brand and model of defibrillator pad is not listed heartstart mrx instructions for use.

• 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: 8418553
• MDR Text Key: 138754078
• Report Number: 1218950-2019-02000
• 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: 03/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3536A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/02/2019
• Initial Date FDA Received: 03/13/2019
• Supplement Dates Manufacturer Received: 03/02/2019
• Supplement Dates FDA Received: 09/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2011
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Weight: 109