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

Device Problem Activation Failure (3270)

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

Event Type  malfunction  

Event Description

Mrs.(b)(6) stated to tech that she needed a new handset for her craftmatic bed because it wasn't working.She states she wanted a new mattress to.Tech explained to her that those beds have been discontinued for many years and we do not have parts and the company that did have parts is no longer in business.The customer id not come to cscs.No injury alleged.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CRAFTMATICE
• Type of Device: BED, THERAPEUTIC, AC-POWERED, ADJUSTABLE HOME-USE
• Manufacturer (Section D): CRAFTMATIC
• MDR Report Key: 17531557
• MDR Text Key: 321413067
• Report Number: MW5138470
• Device Sequence Number: 1
• Product Code: LLI
• 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: 12/03/2015

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
• Patient Sequence Number: 1