DIGI TRAK XT HOLTER RECORDER

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-10-08 for DIGI TRAK XT HOLTER RECORDER manufactured by Philips Medical Systems.

Event Text Entries

[4032119] The customer reported a pt claimed they were shocked by the lead set of a holter device. The device is powered by aaa batteries and is highly unlikely to have delivered a shock to a pt but due to the lack of info, this complaint will be reported in an abundance of caution. The device is being sent back to the (b)(4) facility for eval.
Patient Sequence No: 1, Text Type: D, B5

[11440953] (b)(4). A f/u report will be submitted upon completion of the investigation.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 1218950-2013-04946
• MDR Report Key: 3582011
• Report Source: 06
• Date Received: 2013-10-08
• Date of Report: 2013-09-27
• Date Mfgr Received: 2013-09-27
• Date Added to Maude: 2014-02-26
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: NANCY ATAIDE
• Manufacturer Street: 3000 MINUTEMAN RD.
• Manufacturer City: ANDOVER MA 01810
• Manufacturer Country: US
• Manufacturer Postal: 01810
• Manufacturer Phone: 9786597429
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: DIGI TRAK XT HOLTER RECORDER
• Product Code: MWJ
• Date Received: 2013-10-08
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: PHILIPS MEDICAL SYSTEMS
• Manufacturer Address: 3000 MINUTEMAN RD. ANDOVER MA 01810 US 01810

Patients

Patient Number	Treatment	Outcome	Date
1	0		2013-10-08