BED, MANUAL IHCS5

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 IHCS5 manufactured by Invacare Continuing Care.

Event Text Entries

[20779285] It was reported by the provider that the leg and link assembly is not working on ihcs5 bed to engage the brakes. No patient injury alleged, no additional information provided.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 3003433498-2014-00169
• MDR Report Key: 4037801
• Report Source: 08
• Date Received: 2014-08-26
• Date of Report: 2014-07-28
• Date Mfgr Received: 2014-07-28
• Date Added to Maude: 2014-09-09
• 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: IHCS5
• 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