MAUDE Adverse Event Report: HILL-ROM BATESVILLE TOTALCARE BARIATRIC CAPITAL; BED, FLOTATION THERAPY, POWERED

Model Number P1840DCA000010

Device Problem No Audible Alarm (1019)

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

Event Date 01/20/2023

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found the pcb needed to be replaced.Per the hillrom service manual, the totalcare® bariatric bed and totalcare® bariatric plus therapy system require an effective maintenance program.We recommend that you perform semi-annual preventive maintenance (pm).Pm will minimize downtime due to excessive wear.Unlock the brakes.The system sounds a periodic audible beep, and the brake not set indicator flashes.Make sure the brake not set control is correctly adjusted.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in july 2022.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the pcb to resolve the reported event.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the bed had no audible brake not set alarm.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: TOTALCARE BARIATRIC CAPITAL
• Type of Device: BED, FLOTATION THERAPY, POWERED
• 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: 16250366
• MDR Text Key: 309297145
• Report Number: 1824206-2023-00048
• Device Sequence Number: 1
• Product Code: IOQ
• UDI-Device Identifier: 00887761000865
• UDI-Public: 010088776100086511180206
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122473
• 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
• Report Date: 01/26/2023

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: P1840DCA000010
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/20/2023
• Initial Date FDA Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/06/2018
• 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