MAUDE Adverse Event Report: HILL-ROM BATESVILLE P500 THERAPY SURFACE; BED FLOTATION THERAPY POWERED

Model Number	P005723CAP01
Medical Device Problem Code	Sparking (2595)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The hillrom technician found the power cord needed to be replaced.The p500 surface is for household and healthcare facility use.The p500 surface is a finished size of 35.5" (90 cm) wide by 84".(213 cm) long, with a thickness of 8" (20 cm).The surface is designed for use on pan-deck frames that accommodate this surface size; it is not intended for use on spring-deck frames.The intended users of this product are healthcare employees, non-clinical caregivers, and occupants who have the physical strength and cognitive skills to operate and control the product.Follow safety protocols if an intended user does not have the physical strength or cognitive skills to operate and control the product safely.A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the power cord to resolve the issue.Based on this information, no further action is required.
Event or Problem Description
Hillrom received a report from a hillrom technician stating the bed had power cord damage with sparks.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).

• Brand Name: P500 THERAPY SURFACE
• Common Device Name: BED FLOTATION THERAPY POWERED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 12526292
• Report Number: 1824206-2021-00482
• Device Sequence Number: 5338357
• Product Code: IOQ
• UDI-Device Identifier: 00887761999480
• UDI-Public: 010088776199948011210308
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/24/2021

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
• Operator of Device: No Information
• Device Model Number: P005723CAP01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 09/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1