CARESCAPE B850

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2012-10-03 for CARESCAPE B850 manufactured by Ge Healthcare Finland Oy.

Event Text Entries

[18416614] A loss of monitoring for 5 to 7 minutes was reported. No serious injury or death is associated with this event, and medical intervention was not required. Ge healthcare's investigation is ongoing. A follow up report will be submitted once the investigation has been completed.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 9610105-2012-00035
• MDR Report Key: 2782843
• Report Source: 05,06
• Date Received: 2012-10-03
• Date of Report: 2012-09-04
• Date of Event: 2012-09-04
• Date Mfgr Received: 2012-09-04
• Device Manufacturer Date: 2011-03-01
• Date Added to Maude: 2013-01-18
• 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
• Reporter Occupation: BIOMEDICAL ENGINEER
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: JOY SONSALLA
• Manufacturer Street: 3000 N GRANDVIEW BLVD W450
• Manufacturer City: WAUKESHA WI 53188
• Manufacturer Country: US
• Manufacturer Postal: 53188
• Manufacturer Phone: 2625482661
• Manufacturer G1: GE HEALTHCARE FINLAND OY
• Manufacturer City: HELSINKI
• Manufacturer Country: FI
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CARESCAPE B850
• Generic Name: MONITOR, PHYSIOLOGICAL, PATIENT
• Product Code: MHZ
• Date Received: 2012-10-03
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: GE HEALTHCARE FINLAND OY
• Manufacturer Address: HELSINKI FI

Patients

Patient Number	Treatment	Outcome	Date
1	0		2012-10-03