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

Model Number P7900B100283

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 07/02/2020

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician found the bed software version had to be updated to 1.28.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.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 had to update the bed software version to (b)(4) to resolve the issue.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the bed nurse call was not working.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: 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: harish vishwanathan ; 1069 state route 46 east; batesville, IN 47006 ; 3127289851
• MDR Report Key: 10299906
• MDR Text Key: 200226669
• Report Number: 1824206-2020-00312
• Device Sequence Number: 1
• Product Code: FNL
• 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: 07/02/2020

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 Operator: No Information
• Device Model Number: P7900B100283
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/02/2020
• Initial Date FDA Received: 07/20/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2019
• 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