MAUDE Adverse Event Report: HARD CRIB CRIBS; BED, PEDIATRIC OPEN HOSPITAL

Device Problem Mechanical Problem (1384)

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 alleged a manufacturer hard crib, serial number unknown with a siderail that could not be latched/locked in the upright position.Please find additional contact information below.Reference number: (b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CRIBS
• Type of Device: BED, PEDIATRIC OPEN HOSPITAL
• Manufacturer (Section D): HARD CRIB
• MDR Report Key: 17488560
• MDR Text Key: 320684426
• Report Number: MW5121259
• Device Sequence Number: 1
• Product Code: FMS
• 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: 05/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1