MAUDE Adverse Event Report: HILL-ROM BATESVILLE TC BARIATRIC PLUS W/ AIR; BED, FLOTATION THERAPY, POWERED

Model Number P1840RE200

Device Problem Unintended Movement (3026)

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

Event Date 11/30/2023

Event Type  malfunction  

Manufacturer Narrative

The baxter technician found the siderail control boards needed to be replaced.The totalcare bariatric bed and totalcare bariatric plus therapy system require an effective maintenance program.We recommend that you perform a semi-annual preventative maintenance.Preventative maintenance will minimize downtime due to excessive wear.Test the bed function controls for proper operation of the function and momentary operation.Test all lockout controls and individually check for proper operation.A search of the baxter maintenance records did not show baxter performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.Discomfort is an unpleasant sensation occurring in varying degrees of severity and typically stops once the stimulus is removed.Discomfort may be contained to a discrete area as in an injury or more diffuse as in disorders or diseases and is not life threatening and does not require medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure.In this event, there was no report of medical intervention to preclude permanent impairment of a body function or permanent damage to a body structure, which concludes a serious injury did not occur in this case.However, if the reported malfunction (unintentional movement of the bed articulation) were to recur, it would be likely to cause or contribute to a death or serious injury.The technician replaced the siderail control boards to resolve the reported event.Based on this information, no further action is required.

Event Description

It was reported that the totalcare bed was going up and down by itself and the head of the bed would only articulate in one direction.No patient harm was reported, but the patient was uncomfortable.No medical intervention was reported.The bed was located at the account.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: TC BARIATRIC PLUS W/ AIR
• 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: 18398068
• MDR Text Key: 331393749
• Report Number: 1824206-2023-01463
• Device Sequence Number: 1
• Product Code: IOQ
• 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: 12/27/2023

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: P1840RE200
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/30/2023
• Initial Date FDA Received: 12/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2010
• 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