MAUDE Adverse Event Report: HILL-ROM BATESVILLE ENVELLA BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P0819A

Device Problem Sparking (2595)

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

Event Date 08/17/2022

Event Type  malfunction  

Event Description

Hillrom received a report from a hillrom technician stating that the power cord was faulty, it was sparking and open.The bed was located at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint #: (b)(4).

Manufacturer Narrative

The hillrom technician found the unit power cord needed to be replaced.Per the hillrom service manual, perform annual preventive maintenance procedures to make sure all envella® bed components are functioning as originally designed.The user manual instructs that power cords require inspection routinely to ensure no damage has occurred during use.The manuals also include warnings such as incorrect use or handling may result in damage to the power cord.They also instruct that if damage has occurred remove immediately, and to properly remove the power cord from the electrical outlet during transfer or movement of the device.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in july 6, 2022.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the power cord to resolve the issue.Based on this information, no further action is required.

• Brand Name: ENVELLA BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: melrita gilliam ; 1069 state route 46 east; batesville, IN 47006 ; 3127289851
• MDR Report Key: 15310568
• MDR Text Key: 303315093
• Report Number: 1824206-2022-00381
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/29/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P0819A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/02/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1