MAUDE Adverse Event Report: HILL-ROM, INC. TOTALCARE; BED, AC-POWERED ADJUSTABLE HOSPITAL

Device Problems Deflation Problem (1149); Inflation Problem (1310); Mechanical Problem (1384)

Patient Problem Insufficient Information (4580)

Event Date 06/07/2021

Event Type  malfunction  

Event Description

Bed continues to inflate/deflate constantly.It seems like the motor is constantly running.The bed is very loud and does not provide a quiet/relaxing environment for patients.

• Brand Name: TOTALCARE
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 12106683
• MDR Text Key: 259638400
• Report Number: 12106683
• 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: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2021
• 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: 06/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 26645 DA
• Patient Weight: 48