MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART SLA BATTERY

Model Number M3516A

Device Problem Computer Operating System Problem (2898)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported the user found can't boot up sometimes.There was no reported patient involvement.

Manufacturer Narrative

The serial number initially reported was for the defibrillator.

• Brand Name: HEARTSTART SLA BATTERY
• Type of Device: BATTERY
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman road; andover MA 01810
• Manufacturer Contact: betty harris ; 3000 minuteman road; andover, MA 01810
• MDR Report Key: 5056738
• MDR Text Key: 25131282
• Report Number: 1218950-2015-04810
• Device Sequence Number: 1
• Product Code: DQA
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K001725
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Report Date: 08/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3516A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2003
• 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