MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART MRX; DEFIBRILLATOR

Model Number M3535A

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Code Available (3191)

Event Date 08/30/2019

Event Type  Injury  

Manufacturer Narrative

A follow up report will be submitted upon completion of the investigation.

Event Description

It was reported to philips that when attempting to deliver a shock to a patient, the heartstart mrx monitor / defibrillator generated ¿no shock delivered¿ and ¿high impedance¿ messages.Philips is considering this event to be a serious injury because it is unknown if the patient experienced an adverse event, the outcome of the event is unknown, and it is unknown if the treatment was interrupted.Additional information has been requested.

Manufacturer Narrative

Submission of a report does not constitute an admission that medical personnel, user facility, importer, distributor, manufacturer, or product caused or contributed to the event.

Event Description

It was reported to philips that when attempting to deliver a shock to a patient, the heartstart mrx monitor / defibrillator generated ¿no shock delivered¿ and ¿high impedance¿ messages.The device was reported to be in use on a patient, causing a delay in life-threatening therapy/treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.Multiple requests were made for additional patient/procedure information, however, no additional details were received.The device was evaluated by the customer with assistance from a philips call center representative.The customer stated that they have had the external paddles for almost 11 years.The customer stated the device passed operational testing.The philips call center representative provided troubleshooting information to the customer regarding poor paddle contact.The heartstart mrx instructions for use (publication 453564307761, page 316) instructs the user to ¿make sure paddles are making adequate contact with the patient¿s skin.If the problem persists, replace the paddles." no ecg monitoring strips or case event files were provided to philips for review.The customer was instructed to replace the external paddles due to their age.The device remains at the customer site.

• Brand Name: HEARTSTART MRX
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9107372
• MDR Text Key: 162687860
• Report Number: 1218950-2019-07319
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• PMA/PMN Number: K031187
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 08/30/2019

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: M3535A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2019
• Initial Date FDA Received: 09/23/2019
• Supplement Dates Manufacturer Received: 08/30/2019
• Supplement Dates FDA Received: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening