MAUDE Adverse Event Report: INVACARE CLEVELAND STREET K BASE SEAT LIFTER/TRANSPORTER W/DIGITAL SCALE; LIFT, PATIENT, NON-AC-POWERED

Model Number IH1900SIH3652GW

Device Problem Bent (1059)

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

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Base frame is bent.

Manufacturer Narrative

Additional/updated information was added to reflect the lift being returned to the manufacturer for evaluation.The result of the evaluation was that the base of the lift was bent and the upper right shroud was cracked, which confirmed the original complaint issue.The underlying cause was identified as shipping damage, and it was noted that it was not returned in its original packaging.

Event Description

Base frame is bent.

• Brand Name: K BASE SEAT LIFTER/TRANSPORTER W/DIGITAL SCALE
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): INVACARE CLEVELAND STREET; 899 cleveland street; elyria OH 44036
• Manufacturer (Section G): INVACARE CLEVELAND STREET; 899 cleveland street; elyria OH 44036
• Manufacturer Contact: kevin guyton ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 5932262
• MDR Text Key: 54067905
• Report Number: 1219590-2016-00124
• Device Sequence Number: 1
• Product Code: FSA
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: IH1900SIH3652GW
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/17/2016
• Initial Date FDA Received: 09/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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