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

Model Number P3201K000374

Device Problems Device Alarm System (1012); No Audible Alarm (1019)

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

Event Date 11/03/2022

Event Type  malfunction  

Event Description

Hillrom received a report from a hillrom technician stating the bed alarm 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).

Manufacturer Narrative

No further information is available on the repair of the bed at this time.The investigation is ongoing, however any additional relevant information identified following the completion of the investigation will be submitted in a supplemental report.

Manufacturer Narrative

The hillrom technician attempted to inspect the bed three times, but the account is unable to locate the bed.Per the hillrom user manual, warning: the bed exit alarm system is not intended as a substitute for good nursing practices.The bed exit alarm system must be used in conjunction with a sound risk assessment and protocol.Per the hillrom user manual, if the bed exit alarm does not arm and all three mode indicators are flashing, remove the patient and zero the bed exit system.Per the hillrom service manual, perform annual preventive maintenance procedures to make sure all versacare® bed components are functioning as originally designed.Make sure the brake is not set, and then plug the bed into an applicable power source.A steady alarm comes on.Set the brake.The alarm stops.Repair or replace 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.Hillrom has contacted the account three times asking if they are able to locate the bed with this alleged issue.The account is unable to locate the bed and is no longer looking for it.Based on this information, no further action is required.H3 other text: unable to locate device.3 attempts.

Event Description

Hillrom received a report from a hillrom technician stating the bed alarm 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: VERSACARE 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: brad wheeler ; 1069 state route 46 east; batesville, IN 47006 ; 3128199307
• MDR Report Key: 15894091
• MDR Text Key: 305813144
• Report Number: 1824206-2022-00514
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 03/07/2023

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 Model Number: P3201K000374
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2022
• Initial Date FDA Received: 12/01/2022
• Supplement Dates Manufacturer Received: 11/03/2022
• Supplement Dates FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2012
• 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