MAUDE Adverse Event Report: INVACARE TAYLOR STREET CS BED 9153650455; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number UNKNOWN

Device Problems Collapse (1099); Tear, Rip or Hole in Device Packaging (2385); Device Operates Differently Than Expected (2913); Material Deformation (2976)

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

Event Date 07/17/2015

Event Type  malfunction  

Manufacturer Narrative

The metal attaching the backrest to the bed base has completely sheared off causing the side of the backrest to collapse and leaving a large tear in the metal of the bed base.The alegio is the same /similar to ivc and cs series beds which are manufactured and/or marketed by invacare in the u.S.The alleged incident occurred in the (b)(6).

Event Description

The metal attaching the backrest to the bed base has completely sheared off causing the side of the backrest to collapse and leaving a large tear in the metal of the bed base.The alegio is the same /similar to ivc and cs series beds which are manufactured and/or marketed by invacare in the u.S.The alleged incident occurred in the (b)(6).

• Brand Name: CS BED 9153650455
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer (Section G): INVACARE TAYLOR STREET; 1200 taylor street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 4990288
• MDR Text Key: 23936101
• Report Number: 1525712-2015-04204
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/20/2015
• 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