MAUDE Adverse Event Report: INVACARE CORPORATION CS7 BED, ACP 9153654444; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number NA:IHCS7ACP-C

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The issue was discovered during a preventative maintenance audit of the 250-bed facility.The bed and rails continue to function as intended the only deficiency noted is the end caps would not remain in place exposing the edges of the tubing.The device remains in use by the facility and will not be returned to invacare.  replacement end caps were shipped to the dealer on (b)(6) 2017.

Event Description

It was reported that the end plugs are not staying attached to the assist bar that is utilized on an ihcs7acp-c cs7 bed.The plugs would fall off after being re-attached.

• Brand Name: CS7 BED, ACP 9153654444
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): INVACARE CORPORATION; one invacare way; elyria OH 44035
• Manufacturer (Section G): INVACARE CORPORATION; one invacare way; elyria OH 44035
• Manufacturer Contact: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 7205515
• MDR Text Key: 97948789
• Report Number: 1525712-2018-00006
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 12/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: NA:IHCS7ACP-C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1