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

Model Number P005787RENT02

Device Problem No Audible Alarm (1019)

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

Event Date 10/11/2022

Event Type  malfunction  

Manufacturer Narrative

No further information is available on the repair of the bed at this time.If any additional relevant information is identified following completion of the repair, the additional relevant information will be submitted in a supplemental report.

Event Description

Hillrom received a report from a hillrom technician stating the device had no audible alarm.The device 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

No additional information is available.The repair is considered completed; however there is no further information available to determine what was done to repair the product.The p500 surface is intended to provide patient support for 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 showed hillrom performed preventative maintenance on this bed on july 2022.It is unknown if the facility performed any other preventative maintenance on this bed.The repair is considered completed; however there is no further information available to determine what was done to repair the product.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the device had no audible alarm.The device 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 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: brad wheeler ; 1069 state route 46 east; batesville, IN 47006 ; 3128199307
• MDR Report Key: 15762338
• MDR Text Key: 305256584
• Report Number: 1824206-2022-00491
• Device Sequence Number: 1
• Product Code: FNL
• 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,Followup
• Report Date: 04/26/2023

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/11/2022
• Initial Date FDA Received: 11/09/2022
• Supplement Dates Manufacturer Received: 10/11/2022
• Supplement Dates FDA Received: 04/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2011
• 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