MAUDE Adverse Event Report: HILL-ROM BATESVILLE P3200/P3201 VERSACARE BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number P3200K

Device Problem Communication or Transmission Problem (2896)

Patient Problem No Patient Involvement (2645)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

The hillrom technical support representative performed troubleshooting over the phone with the account, asking the account to replace the side communication cable and then replace the side communication board if the cable replacement did not resolve the issue.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.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 technical support contacted the account two additional times trying to obtain the resolution for this alleged issue.No response has been received from the account.Based on this information, no further action is required.

Event Description

Hillrom technical support received a report from the account stating the bed's nurse call function was not working.The bed was located in med surg 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: P3200/P3201 VERSACARE BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): HILL-ROM BATESVILLE; 1069 state route 46 east; batesville IN 47006
• Manufacturer Contact: lori daulton ; 1069 state route 46 east; batesville, IN 47006 ; 8129312280
• MDR Report Key: 10498027
• MDR Text Key: 208589581
• Report Number: 1824206-2020-00378
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: P3200K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2015
• 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