MAUDE Adverse Event Report: KCI ADVANTA 1600P; BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number ADVANTA P1600

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

Event Description

On march 31, 2011, stryker medical was notified of a potentially reportable complaint involving a product for which stryker is not the manufacturer.The customer reported a kci bed, serial number (b)(6), model advanta p1600 had a broken power cable, broken prong.Please find additional contact information below.N/a.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ADVANTA 1600P
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): KCI
• MDR Report Key: 17524295
• MDR Text Key: 321411515
• Report Number: MW5131242
• Device Sequence Number: 1
• Product Code: FNL
• 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: 04/11/2011

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
• Device Model Number: ADVANTA P1600
• Patient Sequence Number: 1