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

Model Number NA:IH1900S

Device Problem Inadequate or Insufficient Training (1643)

Patient Problem Concussion (2192)

Event Type  Injury  

Manufacturer Narrative

The lift was serviced by tightening the bolts on the arm rest to adjust the tension, and is now working properly.The facility already had a quarterly maintenance system in place for wheelchairs, and they are now adding in the lifts to this maintenance process and will be checked more frequently.There were three complaints called in, and only two serial #'s were known.It is not known which lift caused the injury, therefore we are not filing this medwatch on a specific serial number.Should additional information become available, a supplemental record will be filed.

Event Description

It was reported to invacare, that the arms on the ih1900s seat lifter are loose and have come down and hit a staff member on the head.She was taken to the emergency room, where she was diagnosed with a concussion.

• Brand Name: K BASE SEAT LIFTER/TRANSPORTER W/DIGITAL SCALE
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• 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: jason fiest ; one invacare way; elyria, OH 44035 ; 8003336900
• MDR Report Key: 9721906
• MDR Text Key: 189331369
• Report Number: 1525712-2020-00010
• 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: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NA:IH1900S
• Device Catalogue Number: IH1900S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/05/2020
• 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