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

Model Number P0819A

Patient Problem Insufficient Information (4580)

Event Date 01/07/2024

Event Type  Injury  

Event Description

Situation: a heart mate patient had unexplained pump stops.Background: the patient received a hm3 device on [redacted date] and has been critically ill in the icu post implant.She was placed on a hill rom envella specialty bed on [redacted date] for an unstageable sacral pressure ulcer.It was reported to the heart failure attending on [redacted date] that the patient was having pump stops of unknown etiology.The patients controller and power module were exchanged with recurrence of a pump stop.Assessment: waveforms sent to abbott engineers this morning which confirmed the pump stops were caused by electrostatic discharge.The specialty bed was suspected to be the origin of the electrostatic discharge.Recommendation: the specialty bed was changed out for a regular icu bed; waveforms were sent to abbott to confirm there were no more pump stops after the bed was changed.During the time the patient was on the bed, abbott confirms the stops were happening very often, >40times.On [redacted date] [redacted name] clinical engineering, heart and vascular, recall & defect team, met with abbott & hillrom/baxter per hillrom/baxter: envella mifu only has caution for ekg and eeg, considering changes to include other devices and will start testing lvad (cardiac left ventricular assist device) on [redacted date].Per abbott: they were unsure if their mifu contained any information and would bring this inquiry back to their quality team.[redacted name] questions to hillrom/baxter: are you taking this opportunity to test for devices beyond this cardia device or modify your mifu to make a more general statement about how providers and users should proceed with caution or consideration? they said no, that [redacted name] had only asked them about the lvad.[redacted name] encourages hillrom/baxter to take this opportunity to look into messaging about other critical devices it might interfere with.[redacted name] has since added an alert in our electronic medical record that alerts providers to not order this bed if the patient has a heart pump in place, however our request for consideration is so hillrom/baxter can help us make sure our alert applies to the most comprehensive patient populations/devices.[redacted name] question to abbott: will you consider making any general messaging in your mifu about possible interference from other devices? they said they will consider the question.Manufacturer response for specialty bed, envella (per site reporter) see event notes.

• Brand Name: ENVELLA BED
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 18666962
• MDR Text Key: 334897232
• Report Number: 18666962
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/23/2024

1 Device was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Model Number: P0819A
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/23/2024
• Event Location: Hospital
• Date Report to Manufacturer: 02/08/2024
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown