FLOW SELECTOR PM 1000

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 2001-07-12 for FLOW SELECTOR PM 1000 manufactured by Precision Medical, Inc..

MAUDE Entry Details

• Report Number: 2523148-2001-00001
• MDR Report Key: 342496
• Report Source: 06
• Date Received: 2001-07-12
• Date of Event: 2001-06-30
• Date Facility Aware: 2001-07-10
• Report Date: 2001-07-11
• Date Reported to Mfgr: 2001-07-11
• Date Mfgr Received: 2001-07-11
• Device Manufacturer Date: 2001-04-01
• Date Added to Maude: 2001-07-20
• 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: 0
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: JIM PARKER
• Manufacturer Street: 300 HELD DRIVE
• Manufacturer City: NORTHAMPTON PA 18067
• Manufacturer Country: US
• Manufacturer Postal: 18067
• Manufacturer Phone: 6102626090
• Manufacturer G1: *
• Manufacturer Street: *
• Manufacturer City: *
• Manufacturer Country: *
• Single Use: 3
• Remedial Action: IN
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FLOW SELECTOR
• Generic Name: OXYGEN OUTLET FLOW SELECTOR
• Product Code: BXY
• Date Received: 2001-07-12
• Model Number: PM 1000
• Catalog Number: PM 1000
• Lot Number: 0401
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Eval'ed by Mfgr: Y
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 331834
• Manufacturer: PRECISION MEDICAL, INC.
• Manufacturer Address: 300 HELD DR. NORTHAMPTON PA 18067 US
• Baseline Brand Name: FLOW SELECTOR
• Baseline Generic Name: OXYGEN OUTLET FLOW SELECTOR
• Baseline Model No: PM 1000
• Baseline Catalog No: PM 1000
• Baseline ID: *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	2001-07-12