MAUDE Adverse Event Report: HILL-ROM, INC. P500 BED; BED, FLOTATION THERAPY, POWERED

Device Problem Gas/Air Leak (2946)

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

Event Date 03/20/2023

Event Type  malfunction  

Event Description

Rental p500 bed failed.Air leak noted in hose.This was a rental bed.As returned to company for repair.No harm to patient.

• Brand Name: P500 BED
• Type of Device: BED, FLOTATION THERAPY, POWERED
• Manufacturer (Section D): HILL-ROM, INC.; one baxter parkway; deerfield IL 60015
• MDR Report Key: 16822532
• MDR Text Key: 314085006
• Report Number: 16822532
• 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: 04/21/2023

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?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/21/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/27/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/27/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 32485 DA
• Patient Sex: Female
• Patient Weight: 115 KG