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

Model Number M3535A

Device Problem Failure to Capture (1081)

Patient Problem Injury (2348)

Event Date 11/27/2020

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 device had an abrupt lack of capture during transcutaneous pacing.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.Additional details have been requested.The customer reported two similar events with patient a being addressed in pr (b)(4) and patient b being addressed in this complaint.

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 device had an abrupt lack of capture during transcutaneous pacing.The device was reported to be in use on a patient, causing a delay in life saving therapy/treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.The customer reported two similar events with patient a being addressed in pr 10833064 and patient b being addressed in this complaint.The patient was being treated while in the intensive care unit.The clinicians had to replace the pads three times.Each time they were able to regain pacing capture right away.There was loss of pacing capture, however, no other details were able to be provided by the customer.The customer was not certain if the involved defibrillator was evaluated.There was no report of any failed operational checks or error messages related to the defibrillator.There was no report of harm to the patient as pacing capture was re-established.No ecg monitoring strips or case event files were provided to philips for review.The involved defibrillator pads were not available for evaluation by philips.The customer sent philips a representative set of defibrillator pads from each lot number.These defibrillator pads underwent extensive testing in the philips failure analysis lab.The pads were fully functional and no problems were identified.Philips also searched the complaint database to determine if there had been any previous issues reported for these lot numbers.No complaints were identified.Philips is unable to determine the cause of loss of pacing capture.Pacing capture may be influenced by several factors including the condition of the patient and their medical diagnoses, the ma selection, and pad placement.The device remains with the customer.

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 device had an abrupt lack of capture during transcutaneous pacing.The device was reported to be in use on a patient, causing a delay in life saving therapy/treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.The customer reported two similar events with patient a being addressed in (b)(4) and patient b being addressed in this complaint.The patient was being treated while in the intensive care unit.The clinicians had to replace the pads three times.Each time they were able to regain pacing capture right away.There was loss of pacing capture, however, no other details were able to be provided by the customer.The customer was not certain if the involved defibrillator was evaluated.There was no report of any failed operational checks or error messages related to the defibrillator.There was no report of harm to the patient as pacing capture was re-established.No ecg monitoring strips or case event files were provided to philips for review.The involved defibrillator pads were not available for evaluation by philips.The customer sent philips a representative set of defibrillator pads from each lot number.These defibrillator pads underwent extensive testing in the philips failure analysis lab.The pads were fully functional and no problems were identified.Philips also searched the complaint database to determine if there had been any previous issues reported for these lot numbers.No complaints were identified.Philips is unable to determine the cause of loss of pacing capture.Pacing capture may be influenced by several factors including the condition of the patient and their medical diagnoses, the ma selection, and pad placement.The device remains with the customer.

• Brand Name: HEARTSTART MRX
• Type of Device: DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 10951501
• MDR Text Key: 219905001
• Report Number: 1218950-2020-07500
• 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: foreign,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 11/27/2020

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: M3535A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2020
• Initial Date FDA Received: 12/05/2020
• Supplement Dates Manufacturer Received: 11/27/2020; 11/27/2020
• Supplement Dates FDA Received: 05/04/2021; 05/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening