MAUDE Adverse Event Report: HILL-ROM BARIATRIC BED

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

Stryker medical was notified of a potentially reportable complaint involving a product for which stryker is not the original equipment manufacturer of the reported device.The customer reported that two hill rom bari mattresses needed repairs.Please find additional contact information below.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BARIATRIC BED
• Type of Device: BARIATRIC BED
• Manufacturer (Section D): HILL-ROM
• MDR Report Key: 17527396
• MDR Text Key: 321424766
• Report Number: MW5134328
• Device Sequence Number: 1
• Product Code: OSI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1