MAUDE Adverse Event Report: HILL-ROM ADVANTA; BED, MANUAL

Device Problem Therapeutic or Diagnostic Output Failure (3023)

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

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 alleged a hill-rom advanta, serial number (b)(6), had malfunctioning brakes.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ADVANTA
• Type of Device: BED, MANUAL
• Manufacturer (Section D): HILL-ROM
• MDR Report Key: 17535045
• MDR Text Key: 321521273
• Report Number: MW5141945
• Device Sequence Number: 1
• Product Code: FNJ
• 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: 08/08/2017

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