BED, MANUAL IHCS7

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 2014-08-26 for BED, MANUAL IHCS7 manufactured by Invacare Continuing Care.

Event Text Entries

[4843809] It was reported by the customer that the leg and link assembly is not working to engage the floor lock. No patient injury alleged, no additional information provided.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3003433498-2014-00170
• MDR Report Key: 4036990
• Report Source: 08
• Date Received: 2014-08-26
• Date of Report: 2014-07-28
• Date Mfgr Received: 2014-07-28
• Date Added to Maude: 2014-09-10
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Reporter Occupation: MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 0
• Event Location: 0
• Manufacturer Contact: KAREN LOUGHREN
• Manufacturer Street: ONE INVACARE WAY
• Manufacturer City: ELYRIA OH 44035
• Manufacturer Country: US
• Manufacturer Postal: 44035
• Manufacturer Phone: 8003336900
• Manufacturer G1: INVACARE CANADA
• Manufacturer Street: 570 MATHESON BLVD E UNIT 8
• Manufacturer City: MISSISSAUGA ON L4Z4G4
• Manufacturer Country: CA
• Manufacturer Postal Code: L4Z 4G4
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: BED, MANUAL
• Generic Name: 880.5120
• Product Code: FNJ
• Date Received: 2014-08-26
• Model Number: IHCS7
• Operator: LAY USER/PATIENT
• Device Availability: N
• Device Eval'ed by Mfgr: R
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: INVACARE CONTINUING CARE
• Manufacturer Address: 994 HARGRIEVE ROAD LONDON N6E1P5 CA N6E 1P5

Patients

Patient Number	Treatment	Outcome	Date
1	0	1. Other	2014-08-26