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U.S. Department of Health and Human Services

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

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PHILIPS MEDICAL SYSTEMS HEARTSTART XL+ DEFIBRILLATOR/MONITOR; XL+ DEFIBRILLATOR Back to Search Results
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.
 
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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 Key9520065
MDR Text Key172720458
Report Number1218950-2019-09757
Device Sequence Number1
Product Code MKJ
UDI-Device Identifier00884838023680
UDI-Public(01)00884838023680
Combination Product (y/n)N
PMA/PMN Number
K110825
Number of Events Reported1
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 Number861290
Device Catalogue Number861290
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 12/20/2019
Initial Date FDA Received12/26/2019
Supplement Dates Manufacturer Received12/20/2019
12/20/2019
12/20/2019
Supplement Dates FDA Received03/20/2020
05/22/2020
12/17/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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