MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART XL+ DEFIBRILLATOR/MONITOR; XL+ DEFIBRILLATOR

Model Number 861290

Device Problems Self-Activation or Keying (1557); Defibrillation/Stimulation Problem (1573); Unexpected Shutdown (4019)

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

Event Date 12/18/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported to philips that the device switched off during use after shocking 4 times.It was reported to philips that the alleged failure was observed while the device was in use on a patient.Patient outcome is currently unknown; 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

This reporter stated that a patient of unknown age, gender, height, and weight was admitted to a hospital on an unknown date with the admitting diagnosis not reported.No relevant medical history, relevant past drug history or relevant concomitant medical products were reported.While admitted on (b)(6) 2019, the patient experienced an event with details not reported, hospital staff then initiated cardiopulmonary resuscitation (cpr) efforts and connected the patient to the efficia dfm100.During the rescue efforts, hospital staff disconnected the device from ac power, administered four shocks to the patient; number of joules not reported, and then the device ¿died on the clinical staff¿.Hospital staff then connected the patient to another defibrillator; brand and model not reported.It is unknown if any additional shocks were administered to the patient.There was no adverse event reported and the patient incurred no harm.No relevant laboratory data was reported.

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 the device switched off during use after shocking 4 times.The device was reported to be in use on a patient, causing a delay in therapy/treatment and will be considered a serious injury.However, no direct adverse event to the patient or user was reported.This reporter stated that a patient of unknown age, gender, height, and weight was admitted to a hospital on an unknown date with the admitting diagnosis not reported.No relevant medical history, relevant past drug history or relevant concomitant medical products were reported.While admitted on (b)(6) 2019, the patient experienced an event with details not reported, hospital staff then initiated cardiopulmonary resuscitation (cpr) efforts and connected the patient to the efficia dfm100.During the rescue efforts, hospital staff disconnected the device from ac power, administered four shocks to the patient; number of joules not reported, and then the device ¿died on the clinical staff¿.Hospital staff then connected the patient to another defibrillator; brand and model not reported.It is unknown if any additional shocks were administered to the patient.There was no adverse event reported and the patient incurred no harm.No relevant laboratory data was reported.The customer contacted the philips response center.A philips remote service engineer (rse) provided technical advice to the customer via phone call and email.The device was not evaluated by philips.The customer evaluated the device.The device passed all performance assurance tests and remains with the customer.The customer stated they believe there was no fault of the device and the issue was caused by user error.The efficia dfm100 defibrillator, model# 866199, is substantially similar to the heartstart xl+ defibrillator (model # 861290) and will be reported in the united states under device model # 861290.

Event Description

It was reported to philips that the device switched off during use after shocking 4 times.The device was reported to be in use on a patient, causing a delay in therapy/treatment.However, it was confirmed through investigation that no direct adverse event to the patient or user was reported.This reporter stated that a patient of unknown age, gender, height, and weight was admitted to a hospital on an unknown date with the admitting diagnosis not reported.No relevant medical history, relevant past drug history or relevant concomitant medical products were reported.While admitted on (b)(6) 2019, the patient experienced an event with details not reported, hospital staff then initiated cardiopulmonary resuscitation (cpr) efforts and connected the patient to the efficia dfm100.During the rescue efforts, hospital staff disconnected the device from ac power, administered four shocks to the patient; number of joules not reported, and then the device ¿died on the clinical staff¿.Hospital staff then connected the patient to another defibrillator; brand and model not reported.It is unknown if any additional shocks were administered to the patient.There was no adverse event reported and the patient incurred no harm.No relevant laboratory data was reported.The customer contacted the philips response center.A philips remote service engineer (rse) provided technical advice to the customer via phone call and email.The device was not evaluated by philips.The customer evaluated the device.The device passed all performance assurance tests and remains with the customer.The customer stated they believe there was no fault of the device and the issue was caused by user error.The efficia dfm100 defibrillator, model# 866199, is substantially similar to the heartstart xl+ defibrillator (model # 861290) and will be reported in the united states under device model # 861290.

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 XL+ DEFIBRILLATOR/MONITOR
• Type of Device: XL+ DEFIBRILLATOR
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• MDR Report Key: 9520065
• MDR Text Key: 172720458
• Report Number: 1218950-2019-09757
• Device Sequence Number: 1
• Product Code: MKJ
• UDI-Device Identifier: 00884838023680
• UDI-Public: (01)00884838023680
• Combination Product (y/n): N
• PMA/PMN Number: K110825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/20/2019

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: 861290
• Device Catalogue Number: 861290
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/20/2019
• Initial Date FDA Received: 12/26/2019
• Supplement Dates Manufacturer Received: 12/20/2019; 12/20/2019; 12/20/2019
• Supplement Dates FDA Received: 03/20/2020; 05/22/2020; 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1