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

Model Number PR3200CH000003

Device Problem Defective Alarm (1014)

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

Event Date 03/26/2024

Event Type  malfunction  

Event Description

Baxter received a report from a baxter technician stating the bed exit was not alarming.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 external alarm needed to be replaced.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.A search of the baxter maintenance records did not show baxter performed any preventative maintenance on this bed.I t is unknown if the facility performs preventative maintenance on their beds.The technician replaced the external alarm to resolve the reported event.Based on this information, no further action is required.

• Brand Name: RECOND VERSACARE CONFIG
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 19003864
• MDR Text Key: 339003247
• Report Number: 1824206-2024-00416
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: PR3200CH000003
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/26/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2016
• 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