MAUDE Adverse Event Report: L I N E T SPOL. S R.O. ELEGANZA 3; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 1GZ6A100-24

Device Problem Device Slipped (1584)

Patient Problem Insufficient Information (4580)

Event Date 02/15/2022

Event Type  malfunction  

Event Description

Bed brakes do not consistently lock.Only sometimes, therefore, patient safety issue.Device brought down to engineering/biomed.

• Brand Name: ELEGANZA 3
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): L I N E T SPOL. S R.O.; 13455 bobby lane; elm grove WI 53122
• MDR Report Key: 13666212
• MDR Text Key: 286576979
• Report Number: 13666212
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2022,02/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1GZ6A100-24
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2022
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1