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

Model Number 077524

Device Problems Device Emits Odor (1425); Sparking (2595); Noise, Audible (3273)

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

Event Date 09/12/2022

Event Type  malfunction  

Event Description

The bed began making strange sounds.When the bed was unplugged, there was a brief spark and slight smell of smoke where the plug comes from the bed.Fda safety report id #(b)(4).

• Brand Name: HILLROM ENVELLA
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM, INC.
• MDR Report Key: 15470363
• MDR Text Key: 300649780
• Report Number: MW5112220
• 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: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/20/2022

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: Health Professional
• Device Model Number: 077524
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 19 YR
• Patient Sex: Male
• Patient Weight: 110 KG
• Patient Ethnicity: Hispanic
• Patient Race: White