MAUDE Adverse Event Report: HILL-ROM BATESVILLE P500 MRS CONTROL UNIT; BED, FLOTATION THERAPY, POWERED

Model Number P005787RENT02

Device Problem Material Frayed (1262)

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

Event Date 02/28/2023

Event Type  malfunction  

Event Description

The customer alleged the power cord was cut exposing copper.There was no reported injury.This event was captured under hillrom complaint ref # (b)(4).

Manufacturer Narrative

The hillrom technician found the power cord needed to be replaced.Per the hillrom service manual, the p500 therapy surface requires an effective maintenance program.We recommend that you perform an annual preventative maintenance schedule.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 (b)(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 reported event.Based on this information, no further action is required.

• Brand Name: P500 MRS CONTROL UNIT
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 16618411
• MDR Text Key: 312060938
• Report Number: 1824206-2023-00167
• Device Sequence Number: 1
• Product Code: IOQ
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/27/2023

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: P005787RENT02
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/28/2023
• Initial Date FDA Received: 03/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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