MAUDE Adverse Event Report: HILL-ROM COMPANY, INC. HEAD ADAPTER BRACKET; HOLDER, HEAD, RADIOGRAPHIC

Catalog Number 216054

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pressure Sores (2326)

Event Date 03/27/2023

Event Type  malfunction  

Event Description

Patient was intubated and the care team decided to flip to patient into a prone position, and when the patient was moved into the prone position, staff used the "hill-rom head positioner" and "head adapter bracket" to support the patients head and neck while proning the patient.After approximately 12-16 hours of being in the prone position, staff began to put the patient back into the supine position, and they realized that the patient had developed sores on both of his cheeks where the patient¿s skin was in contact with the "hill-rom head positioner." nursing staff treated the sores and reported the problem to their manager.Manufacturer response for head adapter bracket, (brand not provided) (per site reporter): icu nurse manager has reached out to the hill rom rep, but has not heard anything back after numerous attempts to contact her.

• Brand Name: HEAD ADAPTER BRACKET
• Type of Device: HOLDER, HEAD, RADIOGRAPHIC
• Manufacturer (Section D): HILL-ROM COMPANY, INC.; 4279 u crosspoint drive; ladson SC 29456
• MDR Report Key: 16723468
• MDR Text Key: 313121783
• Report Number: 16723468
• Device Sequence Number: 1
• Product Code: IWY
• 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: 04/07/2023,04/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: 216054
• Device Lot Number: 22-028
• 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: 04/07/2023
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/12/2023
• 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: 22630 DA
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Race: White