INVACARE TRACER TR185A180 *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1997-07-31 for INVACARE TRACER TR185A180 * manufactured by Invacare.

Event Text Entries

[20469276] Resident was seated in wheelchair with seat belt in place around waist. Found 1. 2 hr last observation with her body out of wheelchair buttocks on floor, wheelchair tipped forward and seat belt around neck.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 110332
• MDR Report Key: 110332
• Date Received: 1997-07-31
• Date of Report: 1997-07-30
• Date of Event: 1997-07-25
• Date Facility Aware: 1997-07-25
• Report Date: 1997-07-30
• Date Reported to Mfgr: 1997-07-30
• Date Added to Maude: 1997-08-05
• Event Key: 0
• Report Source Code: User Facility report
• Manufacturer Link: N
• 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
• Single Use: 0
• Previous Use Code: 0
• Event Type: 3
• Type of Report: 3

Device Sequence Number: 1

• Brand Name: INVACARE TRACER
• Generic Name: WHEELCHAIR
• Product Code: IOR
• Date Received: 1997-07-31
• Model Number: TR185A180
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 5 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 1
• Device Event Key: 108374
• Manufacturer: INVACARE
• Manufacturer Address: 899 CLEVELAND ST PO BOX 4028 ELYRIA OH 440362125 US
• Baseline Brand Name: TRACER
• Baseline Generic Name: MECHANICAL WHEELCHAIR
• Baseline Model No: TRACER/PLUS/LX/
• Baseline Catalog No: TR18SA180
• Baseline ID: NA
• Baseline Device Family: MECHANICAL WHEELCHAIR
• Baseline Shelf Life [Months]: NA
• Baseline PMA Flag: N
• Baseline 510K PMN: Y
• Premarket Notification: K935398
• Baseline Preamendment: N
• Baseline Transitional: N
• 510k Exempt: N

Device Sequence Number: 2

• Brand Name: IMM INCORPORATED
• Generic Name: SEAT BELT
• Product Code: IQB
• Date Received: 1997-07-31
• Model Number: *
• Catalog Number: *
• Lot Number: NUMBER 92 NUMBER 05
• ID Number: PATENT #4,128,924 A 30,023
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Device Age: 5 YR
• Implant Flag: N
• Date Removed: *
• Device Sequence No: 2
• Device Event Key: 108382
• Manufacturer: IMM INC
• Manufacturer Address: * * *

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Death	1997-07-31