AUSTIN HEALTHMATE PLUS 393639 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-01-13 for AUSTIN HEALTHMATE PLUS 393639 * manufactured by Austin Air Systems, Inc..

Event Text Entries

[17435933] Rptr purchased 2 air purifiers in 1993 and one in 1994; all three were mfg in 1993. Caller reports that she has had ongoing problems with the devices not working well and delivering poor air quality. Rptr has spent hundreds of dollars on the devices themselves, as well as expenses in purchasing new air filters. The devices have a 5 year warrenty. Rptr claims that she replaces the air filters to get purer air, however she can not get filters for the 1993 model. Instead she was given 1994 model air filters that actually break open and deliver particles into the air. The devices are covered in black carbon. Rptr attributes use of these devices to a recent bronchitis infection. Rptr has contacted the mfr multiple times regarding the warranty, quality and the expense, however rptr claims that the mfr offered to collect the devices and send new ones for payment.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1015437
• MDR Report Key: 206037
• Date Received: 1999-01-13
• Date of Report: 1999-01-13
• Date of Event: 1995-01-01
• Date Added to Maude: 1999-01-19
• 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
• Reporter Occupation: PATIENT
• 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: AUSTIN HEALTHMATE PLUS
• Generic Name: AIR PURIFIER
• Product Code: FRF
• Date Received: 1999-01-13
• Model Number: 393639
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 200004
• Manufacturer: AUSTIN AIR SYSTEMS, INC.
• Manufacturer Address: 701 SENECA ST. BUFFALO NY 14210 US

Device Sequence Number: 2

• Brand Name: AUSTIN HEALTHMATE PLUS
• Generic Name: AIR PURIFIER
• Product Code: FRF
• Date Received: 1999-01-13
• Model Number: 9304221
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 2
• Device Event Key: 200006
• Manufacturer: AUSTIN AIR SYSTEMS, INC.
• Manufacturer Address: 701 SENECA ST. BUFFALO NY 14210 US

Device Sequence Number: 3

• Brand Name: AUSTIN HEALTHMATE PLUS
• Generic Name: AIR PURIFIER
• Product Code: FRF
• Date Received: 1999-01-13
• Model Number: 393640
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: LAY USER/PATIENT
• Device Availability: Y
• Device Age: *
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 3
• Device Event Key: 200007
• Manufacturer: AUSTIN AIR SYSTEMS, INC.
• Manufacturer Address: 701 SENECA ST. BUFFALO NY 14210 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-01-13