PIKO 1 * 345010

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2004-08-17 for PIKO 1 * 345010 manufactured by Pds-ferraris Cardio Respiratory.

Event Text Entries

[20923011] Both peak flow and fev1 reading register too low. This info needed to properly manage asthma. Cause = flap sticks when you blow into it.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1032981
• MDR Report Key: 552809
• Date Received: 2004-08-17
• Date of Report: 2004-08-11
• Date Added to Maude: 2004-11-03
• 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: 3
• 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 Sequence Number: 1

• Brand Name: PIKO 1
• Generic Name: ELECTRONIC PEAK FLOW
• Product Code: BZH
• Date Received: 2004-08-17
• Returned To Mfg: 2004-08-09
• Model Number: *
• Catalog Number: 345010
• Lot Number: *
• ID Number: *
• Device Availability: R
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 542356
• Manufacturer: PDS-FERRARIS CARDIO RESPIRATORY
• Manufacturer Address: 908 MAIN STREET LOUISVILLE CO 80027 US

Device Sequence Number: 2

• Brand Name: PIKO 1
• Generic Name: FEVI METER
• Product Code: BZH
• Date Received: 2004-08-17
• Returned To Mfg: 2004-08-11
• Model Number: *
• Catalog Number: 345010
• Lot Number: *
• ID Number: *
• Device Availability: R
• Device Age: *
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 542358
• Manufacturer: PDS-FERRARIS CARDIO RESPIRATORY
• Manufacturer Address: 908 MAIN STREET LOUISVILLE CO 80027 US

Patients

Patient Number	Treatment	Outcome	Date
1	2004		2004-08-17