MAUDE Adverse Event Report: HILL-ROM BATESVILLE CENTRELLA MED-SURG; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P7900B000011

Device Problem No Audible Alarm (1019)

Patient Problems Fall (1848); Bone Fracture(s) (1870)

Event Date 07/07/2021

Event Type  Injury  

Manufacturer Narrative

The hillrom technician found the bed functioning as designed.The customer wasn't aware of the patient minimum weight to make alarms function.Per the hillrom service manual, it is necessary for the centrella" bed to have an effective maintenance program.We recommend that you do annual preventative maintenance (pm).Make sure the bed exit system operates correctly.Replace parts if necessary.As no serial number was provided for this bed, a search of the hillrom maintenance records for any hillrom performed preventative maintenance on this bed was unable to be completed.It is unknown if the facility performs preventative maintenance on their beds.A leg fracture is a break or crack in the femur, tibia, or fibula.The extent of the break depends on the forces that are involved.Treatment for leg fractures usually involves a combination of surgery, rehabilitation, and medication.The type of surgery used is primarily based on the bones and soft tissues affected or on the severity of the fracture.Although details regarding the patient and treatment for the leg fracture was not provided, surgery is almost always required and therefore meets the definition of a serious injury.Thus this event is reportable.Based on this information, no further action is required.

Event Description

Hillrom received a report from the customer that the patient had exited the bed and fallen.The bed did not alarm when the patient exited the bed and patient fractured their leg.The bed was located at the account.The patient sustained a fractured leg.This report was filed in our complaint handling system as complaint # (b)(4).

• Brand Name: CENTRELLA MED-SURG
• 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: 12228398
• MDR Text Key: 263549426
• Report Number: 1824206-2021-00388
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00887761985162
• UDI-Public: 010088776198516211181015
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: P7900B000011
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/07/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2018
• 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
• Patient Outcome(s): Other