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

Model Number P1840RE200

Device Problem Collapse (1099)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 09/03/2023

Event Type  Injury  

Manufacturer Narrative

It was reported that while 2 staff members were assisting a patient in the totalcare bariatric bed, the end part of the bed collapsed, injuring them.The patient ended up at a 45 degrees angle but was not injured.Specific details of the injuries sustained by the 2 staff members and eventual medical and/or surgical interventions performed could not be provided by the facility's occupational medicine department due to hipaa regulations.However, it was noted that one staff member was transferred to the emergency room for treatment, and the other is being followed by their primary care physician(pcp).Both remain out of work with no return to work in the near future planned due to injuries.This evaluation is for staff member #2, who was transferred under the care of his/her pcp.The¿totalcare® bariatric bed or¿totalcare® bariatric plus therapy system is intended to be used to treat or prevent pulmonary or other complications associated with immobility; to treat or prevent pressure ulcers; or for any other use where medical benefits may be derived from either continuous lateral rotation therapy or percussion/vibration therapy.The¿totalcare® bariatric bed or¿totalcare® bariatric plus therapy system is intended to provide a patient support to be used in health care environments.The¿totalcare® bariatric bed or¿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 acute sub-acute care, post anesthesia care unit (pacu), and sections of the emergency department (ed).¿ the bed's user manual states: "caution: do not stand or sit on the footboard.Damage to equipment may occur.Warning: do not use the product outside the recommended patient characteristics.Patient injury or equipment damage could occur.Warning: do not use the product outside the recommended safe working load.Patient injury or equipment damage could occur." the totalcare bariatric service manual states: "the totalcare bed system requires an effective maintenance program.We recommend that you perform a semi-annual preventative maintenance.Preventative maintenance will minimize downtime due to excessive wear." in relation to the bed's foot end, the service manual also states: "inspect all surfaces for damage and missing parts.Inspect the footboard for physical damage and missing parts.Wipe down the footboard with a facility-approved disinfectant." the bed was removed from service and inspected by a hillrom technician, who noted that the foot hilow weldment had broken.Preventative maintenance was noted to have been performed on 30aug2023.In this event, it is unknown if the reported injury resulted in a permanent impairment of a body function or permanent damage to a body structure as specific details of the injuries sustained by the staff member were not provided, however, based on the report that he/she was transferred under the care of his/her pcp, and has not yet returned to work 1 month after the event, it cannot be excluded that a medical and/or surgical intervention was performed to preclude permanent impairment of body function or permanent damage to a body structure, concluding that a serious injury has likely occurred.Additionally, the exact cause of the reported event (collapse of the foot hilow weldment) is undetermined as the exact sequence of events, and patient weight has not been shared, however, in the event device misuse contributed to the incident, prevention of this type of events is outlined in the device user manual.

Event Description

It was reported that while 2 staff members were assisting a patient in the totalcare bariatric bed, the end part of the bed collapsed, injuring them.This evaluation is for staff member #2, who was transferred under the care of his/her pcp.

• 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: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 17853100
• MDR Text Key: 324713846
• Report Number: 1824206-2023-01135
• 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: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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: 09/03/2023
• Initial Date FDA Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2014
• 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