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

Model Number P7923A03

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/09/2023

Event Type  malfunction  

Event Description

Patient came from floor on their bed.When the operating room staff removed the sheets, the mattress was found to be in poor condition.Bed was taken by operating room staff and removed from service.Photos attached to this report and in this line.May be part of recall 2023040092.We have sent this to our bed management team who is working with baxter on the remediation plan and replacement of the recalled mattress toppers.

• Brand Name: MATTRESS TOPPER
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM, INC.; 1069 state route 46 east; batesville IN 47006
• MDR Report Key: 18344218
• MDR Text Key: 330804793
• Report Number: 18344218
• 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: Nurse
• Type of Report: Initial
• Report Date: 10/12/2023

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
• Device Model Number: P7923A03
• 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: 10/12/2023
• Event Location: Hospital
• Date Report to Manufacturer: 12/18/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/18/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other