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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART XL+ DEFIBRILLATOR/MONITOR; ALS DEFIBRILLATOR MONITOR
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PHILIPS MEDICAL SYSTEMS HEARTSTART XL+ DEFIBRILLATOR/MONITOR; ALS DEFIBRILLATOR MONITOR Back to Search Results
Model Number 861290
Device Problem Communication or Transmission Problem (2896)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
A follow-up report will be submitted once the investigation is completed.
 
Event Description
A customer reported that the device would not recognize the r wave.The device as in use on a patient at the time of the event, however there was no adverse event to the patient or user.
 
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Brand Name
HEARTSTART XL+ DEFIBRILLATOR/MONITOR
Type of Device
ALS DEFIBRILLATOR MONITOR
Manufacturer (Section D)
PHILIPS MEDICAL SYSTEMS
3000 minuteman road
andover MA 01810
Manufacturer (Section G)
PHILIPS MEDICAL SYSTEMS
22100 bothell everett hwy
bothell WA 98021
Manufacturer Contact
jacqueline nishino
3000 minuteman road
andover, MA 01810
9786871501
MDR Report Key8384501
MDR Text Key137799657
Report Number1218950-2019-01680
Device Sequence Number1
Product Code MKJ
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K110825
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/02/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number861290
Device Catalogue Number861290
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/08/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/18/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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