MAUDE Adverse Event Report: CARROLL HEALTHCARE BED, AC-POWERED ADJUSTABLE HOSPITAL

Model Number 011176

Device Problem Positioning Problem (3009)

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 carrol bed serial number (b)(6), had a malfunctioning fowler.Please find additional contact information below.1460488249 this report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Type of Device: BED, AC-POWERED ADJUSTABLE HOSPITAL
• Manufacturer (Section D): CARROLL HEALTHCARE
• MDR Report Key: 17527715
• MDR Text Key: 321190554
• Report Number: MW5134647
• 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: 07/26/2015

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?: No
• Device Model Number: 011176
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1