ABBOTT LIFE CARE BREEZE 175 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1998-02-10 for ABBOTT LIFE CARE BREEZE 175 * manufactured by Abbott Labs..

Event Text Entries

[19156023] Door latch broke off during installation of iv tubing set. Abbott labs reported this is a common problem with these pumps and no longer mfrs these pumps.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1012969
• MDR Report Key: 148093
• Date Received: 1998-02-10
• Date of Report: 1998-02-03
• Date of Event: 1998-02-02
• Date Added to Maude: 1998-02-12
• Event Key: 0
• Report Source Code: Voluntary report
• Manufacturer Link: N
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 0
• Health Professional: 3
• Initial Report to FDA: 0
• Report to FDA: 0
• Event Location: 3
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: ABBOTT LIFE CARE BREEZE 175
• Generic Name: IV PUMP
• Product Code: LDR
• Date Received: 1998-02-10
• Model Number: LIFE CARE BREEZE 175
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 144314
• Manufacturer: ABBOTT LABS.
• Manufacturer Address: ONE ABBOTT PARK RD. ABBOTT PARK IL 600643500 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1998-02-10