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

Model Number P0819A

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 09/19/2019

Event Type  malfunction  

Event Description

Patient was on envella hill rom specialty sand bed.Patient was lying in sand and sand was all over the floor.

• 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: 9139465
• MDR Text Key: 160709247
• Report Number: 9139465
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 09/19/2019

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
• Device Model Number: P0819A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2019
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/19/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/01/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/01/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20075 DA