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

Model Number P0819A

Device Problems Defective Alarm (1014); Deflation Problem (1149)

Patient Problem Pressure Sores (2326)

Event Date 05/21/2019

Event Type  Injury  

Event Description

The pt had muscle flap surgery on (b)(6) 2019, and the first wound dressing change the complete pt turning was on (b)(6) 2019.When the pt was turned to his side, a pressure injury was identified at the lower back.When wound nurse evaluated the pt, she placed her hand underneath the pt's back and noted that the air bladder for the bed was deflated and the pt's lower back made contact with the bed frame.At that time, hill-rom tech was on the unit and agreed with the wound care nurse and stated that the bed should alarm when there is a deflated bladder.The pt was placed on the unit and agreed with the wound care nurse and stated that the bed should alarm when there is a deflated bladder.The pt was placed on a waffle overlay while the bed was exchanged, which was completed on the same day.Hill-rom support ref number is (b)(4).

• Brand Name: HILL-ROM ENVELLA BED
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM, INC.
• MDR Report Key: 8658570
• MDR Text Key: 146890930
• Report Number: MW5087041
• Device Sequence Number: 1
• Product Code: INX
• UDI-Device Identifier: 00887761013834
• UDI-Public: (01)00887761013834(11)1804027
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: P0819A
• Device Lot Number: (21)T117EN1580 # FOUND AFTER U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/30/2019
• 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): Hospitalization
• Patient Age: 53 YR