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

Model Number P7900A000010

Device Problem No Audible Alarm (1019)

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

Event Date 02/17/2022

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found that the internal coiled cables, which connects via a 37 pin connector to the external side communication cable, were stroking against each other causing interference in the nurse call signal resulting in intermediate working of the bed exit signal sent to the nurse call station.Additional information in regards to the third party nurse call provider, indicated the account used a customized 20 pin cable.The technician found the internal coiled cables needed to be shielded and an adapter was provided in order to convert a hillrom 37 pin bed side communication cable connector to the customized 20 pin side communication cable which was specific to the 3rd party nurse call system used by the account.The centrella® smart+ bed is intended for use in healthcare environments as a patient support system to prevent and/or treat pressure injuries.It is intended for a broad patient population as determined appropriate by the caregiver or institution.It is intended for patient populations weighing at least 70 lb (32 kg) and is capable of supporting patients up to 500 lb (227 kg).The centrella® smart+ bed is intended to assist clinical staff by relaying bed data to hospital communication systems for display and monitoring.Per the hillrom service manual, it is necessary for the centrella¿ bed to have an effective maintenance program.We recommend that you do annual preventive maintenance.Make sure the sidecom® communication system junction box is in good condition and all attaching hardware is present and secure.Use the sidecom® tester to make sure the sidecom® communication system operates correctly.Make sure the nurse call indicator is on in all indicator locations.Examine the communication cable, including the male and female pins in the plug.Replace parts as 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.The technician provided an adapter to accommodate the 3rd party nurse call system used by the account to resolve the issue of intermittent bed exit signals sent to the nurses station.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the account had 32 centrella beds that were not sending a bed exit signal to the nurse's station when a patient exited the bed.The beds were located at the account.Individual serial numbers of the affected beds were not provided by the customer.Therefore, hillrom is filing individual initial/final mdrs for each of the 32 centrella beds based on the information available; however, serial number will not be included as the customer did not provide this information to hillrom.There was no patient/user injury reported.This report was filed in our complaint handling system as complaint (b)(4).

• Brand Name: CENTRELLA FRAME
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: keighley crosthwaite ; 1069 state route 46 east; batesville, IN 47006 ; 3128199307
• MDR Report Key: 13658622
• MDR Text Key: 289223956
• Report Number: 1824206-2022-00125
• Device Sequence Number: 1
• Product Code: FLN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/03/2022

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: P7900A000010
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/17/2022
• Initial Date FDA Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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