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

Model Number P1840BRE0001

Device Problem Unintended Movement (3026)

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

Event Date 12/05/2021

Event Type  malfunction  

Manufacturer Narrative

The hillrom service technician inspected the bed at the customer site and found casters need to be replaced.The brakes were not holding properly when the brakes were set.The bed was not functioning as designed per functional testing and was removed from the customer site for repairs to be performed at the warehouse.The totalcare bariatric bed and totalcare bariatric plus therapy system are intended to provide a patient support ideally suited for use in healthcare environments.The totalcare bariatric bed and totalcare bariatric plus therapy system may be used in a variety of settings including, but not limited to, acute care, including critical care, step down/progressive care, medical/surgical, high acuity sub-acute care, post anesthesia care unit (pacu), and sections of the emergency department (ed).The totalcare bariatric bed is capable of being used with a broad patient population whose weight is between 200 and 460 lb (91 to 209 kg) and as determined appropriate by the caregiver or institution.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.Inspect the casters for proper mounting, excessive wear, or tread damage.Replace as needed.Verify proper operation of the brake system.Adjust as necessary.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in jun 29, 2021.It is unknown if the facility performed any other preventative maintenance on this bed.Four new brake casters were installed, and the bed functioned as designed post-repair.Although there was no patient injury reported, it is likely the malfunction could cause or contribute to a serious injury or death if the malfunction were to recur.Hillrom consider this complaint reportable.The technician replace the four casters to resolve the reported issue.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the brakes failed to lock on the totalcare bariatric bed causing the patient to fall from the bed.The patient was not injured, and no medical intervention was reported.The patient was removed from the bed.The bed was located at the account. this report was filed in our complaint handling system as (b)(4).

• Brand Name: TOTALCARE BARIATRIC
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: maritza valencia ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 13012691
• MDR Text Key: 283773340
• Report Number: 1824206-2021-00587
• 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: 12/15/2021

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 Model Number: P1840BRE0001
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/05/2021
• Initial Date FDA Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/15/2010
• 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