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

Model Number P3201K000524

Device Problems No Audible Alarm (1019); Misconnection (1399)

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

Event Date 11/26/2023

Event Type  malfunction  

Manufacturer Narrative

Baxter is in the process of inspecting the versacare bed.There was no allegation of patient or caregiver injury or death reported from this alleged incident.Investigation is ongoing.All additional and relevant information that is identified following completion of the investigation will be submitted in a final report.

Event Description

Baxter received a report from a customer stating the bed exit alarm was not alarming at the nurse station.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).

Event Description

Baxter received a report from a customer stating the bed exit alarm was not alarming at the nurse station.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 baxter technician found the sidecom pcb, communication cable and dummy plug were missing.Per the hillrom service manual, perform annual preventive maintenance procedures to make sure all versacare® bed components are functioning as originally designed.Examine and test the communication junction box.Make sure the sidecom® communication system feature works correctly.Examine the communication cable, include the male and female pins in the plug.This issue would not be likely to cause or contribute to a death or serious injury if the malfunction were to recur as this would be evident to the end user and the bed would show inactive at the nurse's station that the bed communication is not engaged.The technician replaced the sidecom pcb, communication cable and dummy plug to resolve the reported event.Based on this information, no further action is required.

• 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: daniela avila ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 18383187
• MDR Text Key: 331488957
• Report Number: 1824206-2023-01452
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: P3201K000524
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2016
• 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