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

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/05/2019

Event Type  No Answer Provided  

Event Description

Pt on envella specialty bed, upon turning pt, noticed particles leaking out of mattress.All bed controls are working and pt is no distress.Called hillrom bed company multiple times in attempt to get a response as to when new bed can be delivered.Nursing supervisor made aware.Pt placed in our hospital bed while awaiting replacement specialty bed.

• Brand Name: ENVELLA
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 8607245
• MDR Text Key: 144950465
• Report Number: 8607245
• 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: 05/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/13/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 27740 DA