FLOWMETERS (VARIOUS TYPES) IRCPF16

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2013-01-07 for FLOWMETERS (VARIOUS TYPES) IRCPF16 manufactured by Invacare Florida Operations.

Event Text Entries

[18044164] Provider stated cannot make fixed measurement on the flowmeter. No injury is alleged.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 1031452-2013-00044
• MDR Report Key: 2898781
• Report Source: 08
• Date Received: 2013-01-07
• Date of Report: 2013-01-05
• Date Mfgr Received: 2012-12-07
• Device Manufacturer Date: 2012-04-02
• Date Added to Maude: 2013-03-29
• 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: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: LAURA SMITH
• Manufacturer Street: ONE INVACARE WAY
• Manufacturer City: ELYRIA OH 44035
• Manufacturer Country: US
• Manufacturer Postal: 44035
• Manufacturer Phone: 8003336900
• Manufacturer G1: INVACARE FLORIDA OPERATIONS
• Manufacturer Street: 2101 EAST LAKE MARY BLVD
• Manufacturer City: SANFORD FL 32773
• Manufacturer Country: US
• Manufacturer Postal Code: 32773
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: FLOWMETERS (VARIOUS TYPES)
• Generic Name: 868.2300-2340
• Product Code: CAX
• Date Received: 2013-01-07
• Model Number: IRCPF16
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INVACARE FLORIDA OPERATIONS
• Manufacturer Address: 2101 EAST LAKE MARY BLVD SANFORD FL 32773 US 32773

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2013-01-07