MAUDE Adverse Event Report: HILL-ROM; PAIENT BED

Device Problems Mechanical Problem (1384); Defective Device (2588); Noise, Audible (3273)

Patient Problem Insufficient Information (4580)

Event Date 06/25/2021

Event Type  malfunction  

Event Description

Patient bed in room has a motor malfunction.Motor constantly running and revving (sounds like a jet airplane taking off) in a cyclical pattern.Very noisy and distracting to patient.Attempted to unplug and reset the bed with transient improvement.Bed issue is being addressed by bio med department.

• Brand Name: HILL-ROM
• Type of Device: PAIENT BED
• MDR Report Key: 12280509
• MDR Text Key: 265165722
• Report Number: 12280509
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 07/02/2021,06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2021
• 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
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/02/2021
• Event Location: Hospital
• Date Report to Manufacturer: 08/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27010 DA
• Patient Weight: 71