MAUDE Adverse Event Report: INVACARE CORP AL CATH BLUE CATHETER; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number RC350FE (1000033)

Device Problems Break (1069); Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 06/01/2021

Event Type  malfunction  

Event Description

Spoke with daughter (b)(6).She states last week we went out on a service, call as there was a broken screw on the bed, we went out and fixed.She said this week the same thing happened, screw was loose/broken and dad was in a sitting position on the bed and caused him to go flat into a laying down position.(b)(6) said dad didnt fall off the bed just went from a sitting to laying down position.Notes from crm, fst serviced equipment three times, asset that were replaced are r679988 and r680382.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: AL CATH BLUE CATHETER
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): INVACARE CORP
• MDR Report Key: 17534385
• MDR Text Key: 321521644
• Report Number: MW5141286
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Model Number: RC350FE (1000033)
• Patient Sequence Number: 1
• Patient Age: 78 YR