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

Device Problem Unintended System Motion (1430)

Patient Problem Low Oxygen Saturation (2477)

Event Date 07/24/2021

Event Type  Injury  

Event Description

Patient was in a hillrom bed.While intensivist was inserting a central line, the bed went into reverse trendelenburg on its own.Patient decompensated and required a chest tube to be placed.Fda safety report id # (b)(4).

• Brand Name: HILL ROM BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL ROM INC.
• MDR Report Key: 12245485
• MDR Text Key: 264322140
• Report Number: MW5102840
• Device Sequence Number: 1
• Product Code: FNL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 69