MAUDE Adverse Event Report: PHILIPS MEDICAL SYSTEMS HEARTSTART XL

Model Number M4735A

Device Problem Inaccurate Synchronization (1609)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

The customer reported that the device did not sync.There was no patient impact.

Manufacturer Narrative

Pr#: (b)(4).A follow up report will be submitted upon completion of the investigation.

• Brand Name: HEARTSTART XL
• Manufacturer (Section D): PHILIPS MEDICAL SYSTEMS; 3000 minuteman rd.; andover MA 01810
• Manufacturer Contact: kelly rector ; 3000 minuteman rd.; andover, MA 01810 ; 9786592590
• MDR Report Key: 3775991
• MDR Text Key: 15813110
• Report Number: 1218950-2014-01690
• Device Sequence Number: 1
• Product Code: MKJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K001725
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M4735A
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/04/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2004
• 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