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

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/14/2018

Event Type  malfunction  

Event Description

Baxter iv pump reflecting error code and shutting down.It was determined that the envella bed was interfering with the baxter sigma iv pumps.Manufacturer response for bed, envella bed (per site reporter).They provided information to biomed advising that the bed met all fda requirements and that the issue was with the iv pump.

• 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: 7406606
• MDR Text Key: 104678532
• Report Number: 7406606
• 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: 03/21/2018

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 Operator: No Information
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/21/2018
• Event Location: Hospital
• Date Report to Manufacturer: 03/21/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/09/2018
• 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
• Treatment: BAXTER IV PUMPS, VENTILATOR, SCD BOOTS.