MAUDE Adverse Event Report: CARROLL HEALTHCARE CS3 BED 9153651161; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number IHCS7

Device Problems Bent (1059); Break (1069); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/04/2015

Event Type  malfunction  

Event Description

Ihcs7 bed appears to have a bent frame in two locations and a broken motor.She stated the nursing staff heard a loud noise when the bed broke.Only the resident was in the room when this occurred.No further explanation provided on how this occurred.Photos were emailed to technical support to determine what parts needed to be sent out as replacements.Technical support recommended replacing entire bed minus head and footboards and rails.

Manufacturer Narrative

A returned was issued and the product is awaiting receipt and/or evaluation.A follow up will be filed if/when any additional information is provided.

• Brand Name: CS3 BED 9153651161
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): CARROLL HEALTHCARE; 994 hargrieve rd; london, on N6E 1P5; CA N6E 1P5
• Manufacturer (Section G): CARROLL HEALTHCARE; 994 hargrieve rd; london, on N6E 1P5; CA N6E 1P5
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4888805
• MDR Text Key: 6066291
• Report Number: 3003433498-2015-00107
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 06/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IHCS7
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/08/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other