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

Model Number P005723CAP01

Device Problem Sparking (2595)

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

Event Date 09/14/2021

Event Type  malfunction  

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 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
• Type of Device: BED FLOTATION THERAPY POWERED
• 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: 12526292
• MDR Text Key: 273129820
• Report Number: 1824206-2021-00482
• Device Sequence Number: 1
• Product Code: IOQ
• UDI-Device Identifier: 00887761999480
• UDI-Public: 010088776199948011210308
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: No Information
• Device Model Number: P005723CAP01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 09/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/07/2021
• 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