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

Model Number P0819A

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem Shock (2072)

Event Date 02/20/2018

Event Type  malfunction  

Event Description

Nursing reported baxter sigma infusion pump repeatedly alarming ec 341 while connected and infusing to a patient who was in a hill-rom envella bed.Nursing's response was to switch out the pumps when this occurred, but the problem persisted.The pumps were connected to the ac outlet in the patient's room.Additionally, the patient reported being shocked when touching a metal object (nursing call bell, chain on the hill-rom trapeze hanging over his bed).Medical engineering downloaded the pump's history and saw the ec 341 error repeatedly.The engineer ran three pumps together in the patient's room using a demo set in each pump.The pumps ran for an hour without alarming.Nursing then connected one of the pumps to the patient in the envella bed, and within ten minutes, the pump started to alarm and displayed the ec 341 error.An electrical safety check was performed on the bed, and the bed passed.
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manufacturer response for bed, envella (per site reporter).
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hill-rom sent us the attached document on electrostatic discharge.
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manufacturer response for infusion pump, sigma (per site reporter).
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baxter issued a file number and requested that we return the pump.Facility has declined, as it affects multiple pumps and the pump functions properly when not attached to a patient in an envella bed.

• 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: 7321207
• MDR Text Key: 101784307
• Report Number: 7321207
• Device Sequence Number: 1
• Product Code: INX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Model Number: P0819A
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2018
• Event Location: Hospital
• Date Report to Manufacturer: 02/28/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1