MAUDE Adverse Event Report: HILL-ROM, INC. VERSACARE; BED, FLOTATION THERAPY, POWERED

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Inflammation (1932); Pain (1994)

Event Date 02/02/2023

Event Type  malfunction  

Event Description

Patient found by primary rn [redacted name] with right hand stuck in hole/handle in upper bed rail and unable to remove by self or with staff¿s assistance until lubricant was used.Successfully removed shortly after patient found in this condition.Initially patient reported right hand pain, but within minutes denied pain.Patient is confused at baseline.No new abnormalities observed, b/l hands slightly edematous at baseline.Md [redacted name] notified and advised to monitor.It was not a defect but wanted to report since a patient was able to get into that position and caught.

• Brand Name: VERSACARE
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 16564527
• MDR Text Key: 311491277
• Report Number: 16564527
• Device Sequence Number: 1
• Product Code: IOQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/28/2023

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/28/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/17/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1