HEART RATE RESPIRATION MONITOR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-02-02 for HEART RATE RESPIRATION MONITOR * manufactured by Cas Medical Systems, Inc..

Event Text Entries

[440473] The statement of the user that monitor was found to be in the off state in the morning, but did not alarm when doing so. This is after the monitor was charged for 12 hours.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2244861-2006-00002
• MDR Report Key: 671240
• Date Received: 2006-02-02
• Date of Report: 2006-02-02
• Date of Event: 2005-11-01
• Date Mfgr Received: 2005-11-28
• Date Added to Maude: 2006-02-07
• 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: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 0
• Manufacturer Contact: RON JEFFERY
• Manufacturer Street: 44 EAST INDUSTRIAL RD
• Manufacturer City: BRANFORD CT 06405
• Manufacturer Country: US
• Manufacturer Postal: 06405
• Manufacturer Phone: 2034886056
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: HEART RATE RESPIRATION MONITOR
• Generic Name: BREATHING FREQUENCY MONITOR
• Product Code: BZQ
• Date Received: 2006-02-02
• Returned To Mfg: 2005-12-12
• Model Number: *
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 660560
• Manufacturer: CAS MEDICAL SYSTEMS, INC.
• Manufacturer Address: 44 EAST INDUSTRIAL RD. BRANFORD CT 06405 US

Patients

Patient Number	Treatment	Outcome	Date
1	0		2006-02-02