Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEART START XL; DEFIBRILLATOR
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

PHILIPS MEDICAL SYSTEMS HEART START XL; DEFIBRILLATOR Back to Search Results
Model Number M4735A
Device Problem Failure to Deliver Shock/Stimulation (1133)
Patient Problem Alteration In Body Temperature (2682)
Event Type  Injury  
Manufacturer Narrative
A follow up report will be submitted upon completion of the investigation.
 
Event Description
It was reported to philips that the heartstart xl monitor / defibrillator did not shock the patient with 200 joules (j) in sync mode on six attempts, but delivered shock on the seventh attempt.Philips is considering this event to be a serious injury because the treatment was interrupted, it is unknown if the patient experienced an adverse event, and the outcome of the event is unknown.Additional information has been requested.
 
Event Description
It was reported to philips that the heartstart xl monitor / defibrillator did not shock the patient with 200 joules (j) in sync mode on six attempts, but delivered shock on the seventh attempt.Philips is considering this event to be a serious injury because the treatment was interrupted.Even though there was a delay in therapy, the device did convert the arrhythmia into a normal sinus rhythm.A philips field service engineer (fse) evaluated the device.The reported issue was confirmed and traced to a faulty parameter printed circuit assembly (pca).This reporter stated that a 51 years old male patient weighing 95 kilograms with an unknown height, 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) 2020, the patient experienced an event of atrial fibrillation, was having a cryoablation procedure, was administered general anesthesia; drug name, dose, route, and frequency not reported, and was connected to the heartstart xl device via philips multifunction electrode pads; model m3713a, lot number 082919-07, and expiration date: 31aug2021.The hospital staff switched the heartstart xl into sync mode, charged the device with 200 joules (j) of energy, and attempted to shock the patient six times without any shock being delivered.The hospital staff then rebooted the device, checked all connections, then charged and delivered 200 j of a synchronized shock to the patient on the seventh attempt.No adverse event was reported or associated with the use of this device.No relevant laboratory data was reported.Review of the provided ecg rhythm strip showed the device was on 21jan2020, the heart rhythm displayed was consistent with atrial flutter with power line interference (50/60-cycle interference).With the presenting interference, the underlying atrial fibrillation was not displayed.At 09:45:46, a synchronized shock of 199 j of energy was delivered to the patient at 72 ohms.The heart rhythm displayed post shock was consistent with a normal sinus rhythm with power interference.Power line interference was caused by poor electrode placement and or possible non-grounded instrument near the patient (arrhythmia monitoring algorithm, application note, publication number (b)(4), edition 2, august 2011, page 3).This was a malfunction of the parameter pca.The customer declined to repair the device and removed the device from service.The customer will replace the device with new defibrillators from philips.
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
HEART START XL
Type of Device
DEFIBRILLATOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
MDR Report Key9636675
MDR Text Key176608291
Report Number1218950-2020-00633
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
PMA/PMN Number
K001725
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 01/21/2020
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 NumberM4735A
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 01/21/2020
Initial Date FDA Received01/28/2020
Supplement Dates Manufacturer Received01/21/2020
Supplement Dates FDA Received02/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Life Threatening;
Patient Age51 YR
Patient Weight95
-
-