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

Model Number P0819A

Device Problem Electrical Power Problem (2925)

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

Event Date 08/11/2022

Event Type  malfunction  

Event Description

Hillrom received a report from a hillrom technician stating the bed had a wiring issue, power cord was damaged and burnt the power input module.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 power cable and the cable assembly 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 march 2022.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the power cable and the cable assembly to resolve the reported event.Based on this information, no further action is required.

• Brand Name: ENVELLA BED
• Type of Device: BED, AIR FLUIDIZED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: brad wheeler ; 1069 state route 46 east; batesville, IN 47006 ; 3128199307
• MDR Report Key: 15352296
• MDR Text Key: 305638754
• Report Number: 1824206-2022-00393
• Device Sequence Number: 1
• Product Code: INX
• UDI-Device Identifier: 00887761013834
• UDI-Public: 010088776101383411180327
• 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: 09/02/2022

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 Model Number: P0819A
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/11/2022
• Initial Date FDA Received: 09/02/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2018
• 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