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

Model Number P1900K006797

Device Problem Sparking (2595)

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

Event Date 10/18/2021

Event Type  malfunction  

Manufacturer Narrative

The repair is still in process.No further information is available on the repair of the bed at this time.The 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

Hillrom received a report from a hillrom technician stating the bed power cord sparks and smokes where it enters the external outlet.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 power cord had damaged prongs where it connects to the outlet from an unknown problem.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.A search of the hillrom maintenance records showed hillrom performed preventative maintenance on this bed in august 2021.It is unknown if the facility performed any other preventative maintenance on this bed.The technician replaced the power cord to the bed 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 power cord sparks and smokes where it enters the external outlet.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 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: bradley wheeler ; 1069 state route 46 east; batesville, IN 47006 ; 3128199307
• MDR Report Key: 12832185
• MDR Text Key: 280945324
• Report Number: 1824206-2021-00546
• 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: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P1900K006797
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/18/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/04/2007
• 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