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

Model Number P1900AB3763

Device Problem Fire (1245)

Patient Problem No Patient Involvement (2645)

Event Date 12/16/2020

Event Type  malfunction  

Manufacturer Narrative

The hillrom technician went to the account to evaluate the bed.The customer did not provide a serial number of the bed involved and the technician was unable to locate a bed with this alleged issue.Per the hillrom 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.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 hillrom technician attempted to locate the bed with this alleged issue at the request of the customer.The account nor the technician were unable to locate the bed and are no longer looking for it.Based on this information, no further action is required.

Event Description

Hillrom received a report from the customer stating the bed caught fire.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: TOTALCARE BED
• 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: 11155720
• MDR Text Key: 226293737
• Report Number: 1824206-2021-00014
• 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
• Report Date: 12/16/2020

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: P1900AB3763
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2020
• Initial Date FDA Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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