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

Model Number M3536A

Device Problem Unable to Obtain Readings (1516)

Patient Problem Injury (2348)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported to philips the customer was unable to acquire 12 lead ecg for analysis during patient care.The customer performed 5 lead ecg measurement successfully and, based on what was seen, determined 12 lead ecg analysis should be performed.When applying additional 5 lead set, selecting 12 lead, and starting 12 lead ecg acquisition, the device continued to display a 5 lead ecg waveform, and would not acquire a 12 lead ecg.The customer indicated there was harm to the patient, therefore, we are considering this to be a serious injury.The customer stated the patient survived but was unable to provide additional details regarding patient outcome or pre-existing conditions.

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 the customer was unable to acquire 12 lead ecg for analysis during patient care.The customer performed 5 lead ecg measurement successfully and, based on what was seen, determined 12 lead ecg analysis should be performed.When applying additional 5 lead set, selecting 12 lead, and starting 12 lead ecg acquisition, the device continued to display a 5 lead ecg waveform, and would not acquire a 12 lead ecg.The customer indicated there was harm to the patient, therefore, we are considering this to be a serious injury.The customer stated the patient survived.Multiple requests were made for additional patient outcome information and pre-existing conditions, however, no additional details were received.No ecg monitoring strips or case event files were provided to philips for review.A philips repair bench technician evaluated the device and was unable to duplicate the issue.No parts were replaced.The device passed all performance assurance tests and was returned to the customer.Philips was not able to confirm the reported malfunction.Because the problem could not be recreated, the cause cannot be determined.

• Brand Name: HEARTSTART MRX -EMS DEFIBRILLATOR
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10900138
• MDR Text Key: 218168063
• Report Number: 1218950-2020-07204
• 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: 11/03/2020

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: 12/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 11/03/2020
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 76 YR