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

Model Number 861290

Device Problems Computer Software Problem (1112); Defibrillation/Stimulation Problem (1573)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

It was reported that the defibrillator had a software failure ¿ defibrillation blocked.There was reportedly no patient involvement.

• 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 Contact: brian becker ; 3000 minuteman road; andover, MA 01810 ; 9786871501
• MDR Report Key: 10489260
• MDR Text Key: 206567344
• Report Number: 1218950-2020-05116
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K110825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/25/2020
• Initial Date FDA Received: 09/03/2020
• Supplement Dates Manufacturer Received: 08/25/2020
• Supplement Dates FDA Received: 12/07/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1