MAUDE Adverse Event Report: HILL-ROM BATESVILLE P500 MRS CONTROL UNIT; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P005787RENT02

Device Problems Material Frayed (1262); Material Split, Cut or Torn (4008)

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

Event Date 08/14/2023

Event Type  malfunction  

Event Description

Hillrom received a report from a hillrom technician stating the bed had power cord frayed with exposed copper wires.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 cord needed to be replaced.It is necessary for the p500 to have an effective maintenance program.We recommend that you do annual preventive maintenance (pm) and testing for joint commission certification.Pm and testing not only meet joint commission requirements but can help make sure of a long, operative life for the p500.Pm will minimize downtime due to excessive wear.Examine the plug for damage.Make sure the plug is a one-piece molded plug assembly.If it is not, replace the plug cord assembly.Replace any plug cord assembly that shows any of these: discoloration of the plug molding around the plug blades; this could occur if the plug blades have overheated or arced.Any signs of cracking; this could occur if the plug has been bent and straightened to a point past its useful life.Loose fit of the plug blade (the plug blade moves in the molding); this could occur if the molding has overheated or the blades have been bent and straightened to a point past their useful life.Replace the power cord, if damaged.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed on 24/01/2023.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the power cord to resolve the reported event.Based on this information, no further action is required.

• Brand Name: P500 MRS CONTROL UNIT
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: maritza valencia ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 17589535
• MDR Text Key: 321772778
• Report Number: 1824206-2023-00937
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00887761001022
• UDI-Public: 010088776100102211170308
• 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: 08/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P005787RENT02
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/14/2023
• Was Device Evaluated by Manufacturer?: No
• 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