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

Model Number	P005787RENT02
Medical Device Problem Code	No Audible Alarm (1019)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/03/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No further information is available on the repair of the bed at this time.¿ the investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
Event or Problem Description
Baxter received a report from a baxter technician stating the bed exit alarm was not alerting the nurse's station.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).
Event or Problem Description
Baxter received a report from a baxter technician stating the bed exit alarm was not alerting the nurse's station.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).
Additional Manufacturer Narrative
The baxter technician found the¿device was beyond repair and would be scrapped and retired.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 baxter maintenance records showed baxter performed preventative maintenance on this bed in (b)(6) 2023.It is unknown if the facility performed any other preventative maintenance on this bed.The technician scrapped and retired the device as it was beyond repair.¿based on this information, no further action is required.

• Brand Name: P500 MRS CONTROL UNIT
• Common Device Name: 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: 19220563
• Report Number: 1824206-2024-00575
• Device Sequence Number: 12554174
• Product Code: FNL
• UDI-Device Identifier: 00887761001022
• UDI-Public: (01)00887761001022(11)170308
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2024

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2024
• Supplement Date Received by Manufacturer: 04/03/2024
• Initial Report FDA Received Date: 05/01/2024
• Supplement Report FDA Received Date: 09/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/07/2017
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown