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

Model Number 861290

Device Problem Failure to Power Up (1476)

Patient Problem No Code Available (3191)

Event Date 11/13/2019

Event Type  Injury  

Manufacturer Narrative

A follow-up report will be submitted once the investigation is completed.

Event Description

A customer reported that the device did not power on while in use on a patient and that another device was used.Additional information has been requested.This incident will be reported as a serious injury.The customer reported that a replacement device was required in a "very harmful" case.

Event Description

A customer reported that the device did not power on while in use on a patient and that another device was used.The device was reported to be in use on a patient, but no adverse event to patient or user was reported.A philips field service engineer (fse) evaluated the device and discovered a faulty processor pca.The device passed all performance tests.No ecg strips or case events files were provided to philips for evaluation.The information gathered for this report does not provide evidence of a systemic, design, or labeling problem.No further investigation or action is warranted.

• 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 Key: 9351467
• MDR Text Key: 167317722
• Report Number: 1218950-2019-08801
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K110825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/13/2019

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/13/2019
• Initial Date FDA Received: 11/20/2019
• Supplement Dates Manufacturer Received: 11/13/2019
• Supplement Dates FDA Received: 01/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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