APEXPRO TELEMETRY SYSTEM

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 2010-08-20 for APEXPRO TELEMETRY SYSTEM manufactured by Ge Healthcare.

Event Text Entries

[1352268] A customer reported a loss of monitoring (ecg waveform dropout) up to one hour duration for multiple telemetry pts. "no telem" messages were displayed at the central station. No pt injury was reported. Ge healthcare's investigation into the reported occurrence is still ongoing. A follow-up report will be issued when the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2124823-2010-00085
• MDR Report Key: 1818559
• Report Source: 06
• Date Received: 2010-08-20
• Date of Report: 2010-08-20
• Date of Event: 2010-07-22
• Date Mfgr Received: 2010-07-22
• Date Added to Maude: 2011-02-03
• 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: 0
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: DEBRA LAHR
• Manufacturer Street: 540 W NORTHWEST HIGHWAY
• Manufacturer City: BARRINGTON IL 600103076
• Manufacturer Country: US
• Manufacturer Postal: 600103076
• Manufacturer Phone: 8472774472
• Manufacturer G1: GE HEALTHCARE
• Manufacturer City: MILWAUKEE WI
• Manufacturer Country: US
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: APEXPRO TELEMETRY SYSTEM
• Generic Name: TELEMETRY MONITORING SYSTEM
• Product Code: GYE
• Date Received: 2010-08-20
• Device Availability: Y
• Device Age: DA
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GE HEALTHCARE
• Manufacturer Address: MILWAUKEE WI US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2010-08-20