MAUDE Adverse Event Report: HILL-ROM BATESVILLE VERSACARE FRAME; BED, FLOTATION THERAPY, POWERED

Model Number P3201

Device Problem Defective Alarm (1014)

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

Event Date 07/01/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported that the brake alarm was not sounding when the brake was released.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.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.Hillrom has contacted the account requesting repair of the bed with this alleged issue.The account is scrapping the bed due to age and refused for a repair.Based on this information, no further action is required.

Event Description

Hillrom received a report from a hillrom technician stating the bed had no audible brake not set alarm.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, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: harish vishwanathan ; 1069 state route 46 east; batesville, IN 47006 ; 3127289851
• MDR Report Key: 12573048
• MDR Text Key: 274795715
• Report Number: 1824206-2021-00492
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/04/2021

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: P3201
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/01/2019
• Initial Date FDA Received: 10/04/2021
• Was Device Evaluated by Manufacturer?: No
• 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