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

Model Number P1900Q007045

Device Problems Fire (1245); Melted (1385)

Patient Problem No Patient Involvement (2645)

Event Date 02/04/2019

Event Type  malfunction  

Manufacturer Narrative

The hill-rom technician found the power cord was burned and needed to be replaced.No other issues were found with the bed.The account is still investigating the cause of the fire.Per the hill-rom service manual the totalcare bed system requires an effective maintenance program.We recommend that you perform a semi-annual preventative maintenance.Preventative maintenance will minimize downtime due to excessive wear.Examine the power cords and plugs for cuts, nicks, breaks, frays and for correct grounding.A search of the hill-rom maintenance records showed hill-rom performed preventative maintenance on this bed in 2017.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the power cord to resolve the bed issue.The accounts investigation is ongoing, however if any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.

Event Description

Hill-rom received a report from the account stating the room outlet caught fire and the power cord was melted.The bed was located in the sicu at the account.There was no patient/user injury reported.This report was filed in our complaint handling system as (b)(4).

Manufacturer Narrative

The power cord was returned to the vendor for analysis.Their results showed that the power cord blades had internal damage that may have caused electrical arching resulting in the solder region to heat up.The internal damage was caused by improper use of the plug.Based on this information, no further action is required.

Event Description

Hill-rom received a report from the account stating the room outlet caught fire and the power cord was melted.The bed was located in the sicu 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: TOTALCARE 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: emily mitchell ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 8317008
• MDR Text Key: 135695236
• Report Number: 1824206-2019-00053
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K962942
• 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,Followup
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: P1900Q007045
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/04/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1