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

Model Number P3200D000160-1

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 05/24/2021

Event Type  Death  

Manufacturer Narrative

The customer reported that the patient fell out of the bed and subsequently expired.The customer also reported that details of the event including patient identification and type/model of the bed were not known.Multiple attempts to obtain additional details of the event including; injury from the fall, medical intervention provided, cause and date of patient's death, alleged malfunction (if any), and confirmation of the use of a hillrom device at the time of the event have been unsuccessful.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.Due to the limited details available at the time, it can not be determined if a hillrom device caused or contributed to this event, therefore hillrom is conservatively reporting this event.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.

Event Description

Hillrom received a report from a hillrom technician stating that the patient fell out of bed.The bed was located at the account.There was a patient death 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: kayla miller ; 1069 state route 46 east; batesville, IN 47006 ; 8129310130
• MDR Report Key: 11992539
• MDR Text Key: 255982272
• Report Number: 1824206-2021-00311
• 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: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: P3200D000160-1
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/24/2021
• Initial Date FDA Received: 06/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Death