CARDIOCAP 5

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2014-06-12 for CARDIOCAP 5 manufactured by Ge Healthcare, Finland Oy.

Event Text Entries

[4621782] The customer reported the unit cannot be switched on and smoke was coming out of the housing. It was not reported whether a patient was connected to the monitor at the time.
Patient Sequence No: 1, Text Type: D, B5

[12053709] Patient data not currently available. Incident unk at this time. Manufacture date is unknown at this time. A follow-up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10

MAUDE Entry Details

• Report Number: 9610105-2014-00013
• MDR Report Key: 3955488
• Report Source: 01,05,06
• Date Received: 2014-06-12
• Date of Report: 2014-05-13
• Date Mfgr Received: 2014-05-13
• Date Added to Maude: 2014-07-31
• 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: DEB LAHR
• Manufacturer Street: 540 W. NORTHWEST HWY
• Manufacturer City: BARRINGTON IL 60010
• Manufacturer Country: US
• Manufacturer Postal: 60010
• Manufacturer Phone: 8472774472
• Manufacturer G1: GE HEALTHCARE
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CARDIOCAP 5
• Generic Name: MONITOR, ST SEGMENT WITH ALARM
• Product Code: MLD
• Date Received: 2014-06-12
• 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		2014-06-12