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 Number1031452-2013-00044
MDR Report Key2898781
Report Source08
Date Received2013-01-07
Date of Report2013-01-05
Date Mfgr Received2012-12-07
Device Manufacturer Date2012-04-02
Date Added to Maude2013-03-29
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationMEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactLAURA SMITH
Manufacturer StreetONE INVACARE WAY
Manufacturer CityELYRIA OH 44035
Manufacturer CountryUS
Manufacturer Postal44035
Manufacturer Phone8003336900
Manufacturer G1INVACARE FLORIDA OPERATIONS
Manufacturer Street2101 EAST LAKE MARY BLVD
Manufacturer CitySANFORD FL 32773
Manufacturer CountryUS
Manufacturer Postal Code32773
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameFLOWMETERS (VARIOUS TYPES)
Generic Name868.2300-2340
Product CodeCAX
Date Received2013-01-07
Model NumberIRCPF16
OperatorLAY USER/PATIENT
Device AvailabilityN
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerINVACARE FLORIDA OPERATIONS
Manufacturer Address2101 EAST LAKE MARY BLVD SANFORD FL 32773 US 32773


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2013-01-07

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