KCI KINAIR *

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1999-01-21 for KCI KINAIR * manufactured by Kinetic Concepts, Inc..

Event Text Entries

[144423] Controls not functioning. Turing pt further than ordered. No pt injury. Pt with 90 pounds garder wells tongs.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: MW1015490
• MDR Report Key: 207281
• Date Received: 1999-01-21
• Date of Report: 1998-12-31
• Date of Event: 1998-11-17
• Date Added to Maude: 1999-01-26
• 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: RISK MANAGER
• 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 Details

• Brand Name: KCI
• Generic Name: ROTOREST BED
• Product Code: INY
• Date Received: 1999-01-21
• Model Number: KINAIR
• Catalog Number: *
• Lot Number: *
• ID Number: *
• Operator: HEALTH PROFESSIONAL
• Device Availability: Y
• Implant Flag: N
• Date Removed: A
• Device Sequence No: 1
• Device Event Key: 201199
• Manufacturer: KINETIC CONCEPTS, INC.
• Manufacturer Address: 4958 STOUT DR. SAN ANTONIO TX 78219 US

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	1999-01-21