MAUDE Adverse Event Report:; BED, AC-POWERED ADJUSTABLE HOSPITAL

Device Problem Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 07/02/2020

Event Type  malfunction  

Event Description

Bed alarm was on and it did not sound off when tested.

• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• MDR Report Key: 15892918
• MDR Text Key: 304682629
• Report Number: 15892918
• 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: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 04/13/2022
• Date Report to Manufacturer: 04/19/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 31755 DA
• Patient Sex: Male