CARDIOCAP 5

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 2012-09-24 for CARDIOCAP 5 manufactured by Ge Healthcare Finland Oy.

Event Text Entries

[2884270] The customer reported the cardiocap 5 did not have any audio. There was no reported pt injury associated with this event. A follow-up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: D, B5

[10137413] The occupation of the reporter is unknown.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 9610105-2012-00034
• MDR Report Key: 2762755
• Report Source: 06
• Date Received: 2012-09-24
• Date of Report: 2012-08-29
• Date of Event: 2012-08-29
• Date Mfgr Received: 2012-08-29
• Device Manufacturer Date: 2006-02-01
• Date Added to Maude: 2013-01-11
• 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: 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: CARDIOCAP 5
• Generic Name: MULTI-PARAMETER PATIENT MONITOR
• Product Code: MLD
• Date Received: 2012-09-24
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: DA
• 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		2012-09-24