MAUDE Adverse Event Report: HILL-ROM, INC. ENVELLA¿ BED; BED, AIR FLUIDIZED

Model Number P0819A

Device Problems Output Problem (3005); Unexpected Shutdown (4019)

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

Event Date 01/15/2023

Event Type  malfunction  

Event Description

Hillrom bed emits electrostatic discharge.On two separate occasions, a patient with a left ventricular assist device (lvad) was placed in a hillrom envella bed.The lvad was alarming fault.The lvad was stopping and restarted.Controller change out was done, alarm resolved.Controller sent to abbott - no issue found.Lvad log files were obtained showing that an electrostatic discharge was the cause of the lvad pump issues.It was learned a day after the second instance, that the hillrom envella beds emits electrostatic electricity that has interfered with medical devices.

• Brand Name: ENVELLA¿ BED
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM, INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 16643909
• MDR Text Key: 312332479
• Report Number: 16643909
• Device Sequence Number: 1
• Product Code: INX
• 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: 02/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P0819A
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/10/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/30/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/30/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male