BERNOULLI MANAGEMENT SYSTEM 3274

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-10-27 for BERNOULLI MANAGEMENT SYSTEM 3274 manufactured by Cpc (vendor).

Event Text Entries

[30041408] (b)(4). Return of the device for investigation was requested, however to date the customer has not returned it.
Patient Sequence No: 1, Text Type: N, H10

[30041409] The system was "freezing" with the display not updating and the watchdog bars at the left top of the screen not sequencing.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 2936999-2015-00904
• MDR Report Key: 5182292
• Date Received: 2015-10-27
• Date of Report: 2015-10-01
• Date of Event: 2015-09-30
• Date Mfgr Received: 2015-10-01
• Device Manufacturer Date: 2014-07-18
• Date Added to Maude: 2015-10-27
• 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: 3
• Event Location: 3
• Manufacturer Contact: THOM MCNAMARA
• Manufacturer Street: 15 HAMPSHIRE STREET
• Manufacturer City: MANSFILED MA 02048
• Manufacturer Country: US
• Manufacturer Postal: 02048
• Manufacturer Phone: 5084524811
• Manufacturer G1: CPC (VENDOR)
• Manufacturer Country: US
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 0

Device Details

• Brand Name: BERNOULLI MANAGEMENT SYSTEM
• Generic Name: OXINET III
• Product Code: MOD
• Date Received: 2015-10-27
• Model Number: 3274
• Catalog Number: 3274
• Operator: HEALTH PROFESSIONAL
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: CPC (VENDOR)
• Manufacturer Address: 200CASCADE BLVD. MILFORD CT 06460 US 06460

Patients

Patient Number	Treatment	Outcome	Date
1	0		2015-10-27