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

Model Number M3536A

Device Problem Inappropriate/Inadequate Shock/Stimulation (1574)

Patient Problem Shock from Patient Lead(s) (3162)

Event Date 02/04/2021

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 cpr, the device shocked a patient, the device monitor said shock delivered and was recorded, however, the patient didn¿t jump.The device was reported to be in use on a patient, causing a delay in life saving therapy and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.

Event Description

It was reported to philips that, during cpr, the device shocked a patient, the device monitor said shock delivered and was recorded, however, the patient didn't jump.The device was reported to be in use on a patient, causing a delay in life saving therapy and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.A philips field service engineer (fse) evaluated the device and was unable to duplicate the issue.No ecg monitoring strips or case event files were provided to philips for review.The heartstart mrx instructions for use (publication 453564307761, page 67) explains that ¿the presence or absence of a muscular response to the transfer of energy during electrical therapy is not a reliable indicator of energy delivery or device performance.¿ no parts were replaced.The device passed all performance assurance tests and was placed back into use with the customer.Philips was not able to confirm the reported malfunction.Because the problem could not be recreated, the cause cannot be determined.

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.

• Brand Name: HEARTSTART MRX -EMS DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 22100 bothell everett hwy; bothell WA 98021
• MDR Report Key: 11333254
• MDR Text Key: 232010705
• Report Number: 3030677-2021-00487
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838006652
• UDI-Public: (01)00884838006652
• 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: 02/04/2021

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
• Device Catalogue Number: M3536A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/04/2021
• Initial Date FDA Received: 02/16/2021
• Supplement Dates Manufacturer Received: 02/04/2021
• Supplement Dates FDA Received: 03/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1