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

Model Number P7900B100010

Device Problem Smoking (1585)

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

Event Date 01/13/2023

Event Type  malfunction  

Event Description

Hillrom received a report from a hillrom technician stating the bed usb port was smoking.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).

Manufacturer Narrative

The hillrom technician found the usb port needed to be replaced.The external alarm is the source of the brake not set alarm and local bed exit alarm.Per the hillrom service manual, do not allow the conductive parts of the patient charging cable, to come into contact with other conductive parts, this includes earth ground.Otherwise, an electrical short might occur, risking electric shock to the patient and damage to their portable electronic device.The usb charging port may not be compatible with all devices.The usb charging port can be used to charge personal electronic devices (ped) such as cell phones, computer tablets, portable media players, and pocket computers.The port is not designed for devices that require less than 170 ma of power such as usb reading lights,but supports up to 2.4 a of current.A search of the hillrom maintenance records did not show hillrom performed any preventative maintenance on this bed.It is unknown if the facility performs preventative maintenance on their beds.The technician replaced the usb port to resolve the reported event.Based on this information, no further action is required.

• 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: 16223431
• MDR Text Key: 308477937
• Report Number: 1824206-2023-00040
• Device Sequence Number: 1
• Product Code: FNL
• UDI-Device Identifier: 00887761985162
• UDI-Public: 010088776198516211200124
• 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: 01/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P7900B100010
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/24/2020
• 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