MAUDE Adverse Event Report: UNKNOWN BED; BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/28/2024

Event Type  malfunction  

Event Description

The reporter called regarding bed which is used by his wife.The reporter mentioned that one wheel of the bed is broken two days ago and is afraid it may lead to any kind of harm to his wife.The bed given by reporter's daughter.

• Brand Name: BED
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18826074
• MDR Text Key: 336914720
• Report Number: MW5152257
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 03/01/2024

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/01/2024
• Patient Sequence Number: 1
• Patient Sex: Female