MAUDE Adverse Event Report: HILL-ROM, INC. LOW AIR LOSS MATTRESS TOTAL SPORT MODEL FRAME; MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE

Model Number P1900P006970

Device Problems Therapeutic or Diagnostic Output Failure (3023); Unintended Deflation (4061)

Patient Problem Pressure Sores (2326)

Event Date 04/24/2023

Event Type  Injury  

Event Description

Patient presented with stage ii pressure wound to sacrum.Order placed for low air loss mattress.Wound progressed.On examination found that air mattress was not functioning and that patient had been lying on bedframe for unknown length of time.Mattress replaced and failed mattress removed from service.Hillrom contacted to come inspect air mattress.

• Brand Name: LOW AIR LOSS MATTRESS TOTAL SPORT MODEL FRAME
• Type of Device: MATTRESS, AIR FLOTATION, ALTERNATING PRESSURE
• Manufacturer (Section D): HILL-ROM, INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 16952793
• MDR Text Key: 315464157
• Report Number: 16952793
• Device Sequence Number: 1
• Product Code: FNM
• 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: 04/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: P1900P006970
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/27/2023
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 18250 DA
• Patient Sex: Female
• Patient Race: Black Or African American