MAUDE Adverse Event Report: HILL-ROM BATESVILLE TC BARIATRIC PLUS W/ AIR; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P1840RE200

Device Problem Material Twisted/Bent (2981)

Patient Problem Fall (1848)

Event Date 05/18/2021

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found that the side rail was broken.It was reported that the patient was leaning over the side rail when it broke.The patient caught himself with his hands on tray table, patient put feet on the floor and did not fall all the way.The technician saw the siderail was broken, but it would latch and stay up, but was pushed out.The side rail was bent.Per the hillrom user manual: applying more than 100 lb (45.5 kg) of additional outward force on a side rail while a patient is laying against it may create an unstable bed situation.Care should be taken when the patient is against the side rail and outward force is used to move the patient.Failure to do so can cause personal injury.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed on november 14, 2020.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the siderail d-pin to resolve the issue.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating that the total care bed¿s siderail was broken and the patient fell out of bed.Follow-up with the customer found that there was no injury to the patient.The customer stated that the patient was leaning over the siderail and the siderail broke.The patient caught himself on the bedside, put his feet on the floor and did not fall all the way.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: TC BARIATRIC PLUS W/ AIR
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• 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: 11957461
• MDR Text Key: 254858345
• Report Number: 1824206-2021-00286
• Device Sequence Number: 1
• Product Code: FNL
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P1840RE200
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/18/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1