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

Model Number M3535A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

A customer reported that a patient was burned with defibrillator pads.Additional information has been requested from the customer.

Event Description

A customer reported that a patient was burned with defibrillator pads.After a full review of all available information, it has been determined that superficial soft tissue redness with no treatment is an expected outcome of pad usage.No additional evaluation is needed as skin redness is expected.There was no allegation of a malfunction.The heartstart adult/child pad instructions for use states: "misuse or misapplication of any electrode pad may result in patient burns or ineffective therapy.(note: reddening of the skin is normal.)".

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.

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

A customer reported that a patient was burned with defibrillator pads.The customer reported the patient was in the emergency room and three shocks were delivered at 150, 200, and 200 joules.The customer noted a small area of superficial soft tissue burn from the pads.There was no note of a requirement for treatment.After a full review of all available information, it has been determined that superficial soft tissue redness with no treatment is an expected outcome of pad usage.No additional evaluation is needed as skin redness is expected.There was no allegation of a malfunction.The heartstart adult/child pad instructions for use states: "misuse or misapplication of any electrode pad may result in patient burns or ineffective therapy.(note: reddening of the skin is normal.)".

• Brand Name: HEARTSTART MRX
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9991559
• MDR Text Key: 189000433
• Report Number: 1218950-2020-02458
• 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,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 04/17/2020
• Initial Date FDA Received: 04/23/2020
• Supplement Dates Manufacturer Received: 04/17/2020; 04/17/2020
• Supplement Dates FDA Received: 06/11/2020; 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1