MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CAREASSIST BED; BED, AC-POWERED ADJUSTABLE HOSPITAL

Device Problem Unintended System Motion (1430)

Patient Problems Fall (1848); Pain (1994)

Event Date 06/08/2023

Event Type  malfunction  

Event Description

Patient was sitting on the side of the bed when the bed malfunctioned (abruptly descending to floor without warning).The patient fell to the ground with pain post event.Manufacturer response for careassist bed, hillrom (per site reporter) working to identify cause of malfunction.

• Brand Name: CAREASSIST BED
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 17181394
• MDR Text Key: 317670383
• Report Number: 17181394
• Device Sequence Number: 1
• Product Code: FNL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/12/2023

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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/12/2023
• Device Age: 10 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/22/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 19710 DA
• Patient Sex: Female
• Patient Weight: 98 KG
• Patient Race: White