PHILLIPS MEDICAL M2601A *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-05-17 for PHILLIPS MEDICAL M2601A * manufactured by Phillips Medical Systems.

Event Text Entries

[336124] A pt was noted by cardiac monitor to be asystole. No audible alarm had sounded. A code was initiated, but the pt expired. Investigation revealed the alarms had been silenced. The monitor has software that allows all alarms to be silenced. There was no malfunction.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 525741
• MDR Report Key: 525741
• Date Received: 2004-05-17
• Date of Report: 2004-05-14
• Date of Event: 2004-04-30
• Date Facility Aware: 2004-04-30
• Report Date: 2004-05-14
• Date Reported to FDA: 2004-05-14
• Date Reported to Mfgr: 2004-05-14
• Date Added to Maude: 2004-05-21
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• 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: 3
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: PHILLIPS MEDICAL
• Generic Name: TELEMETRY SYSTEM
• Product Code: GYE
• Date Received: 2004-05-17
• Model Number: M2601A
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: NO INFO
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 514878
• Manufacturer: PHILLIPS MEDICAL SYSTEMS
• Manufacturer Address: 3000 MINUTEMAN RD ANDOVER MA 01810 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2004-05-17