MAUDE Adverse Event Report: STRYKER MEDICAL - KALAMAZOO CUB PEDIATRIC CRIB; BED, PEDIATRIC OPEN HOSPITAL

Model Number CUB

Device Problem Insufficient Information (3190)

Patient Problem Physical Entrapment (2327)

Event Date 05/10/2015

Event Type  No Answer Provided  

Event Description

A (b)(6) year old was in a styker cub crib on an acute care floor unattended for several minutes.During the time he was unattended - he managed to climb out the top of the styker cub crib and become trapped with his head outside the crib and body remaining inside the crib.

• Brand Name: CUB PEDIATRIC CRIB
• Type of Device: BED, PEDIATRIC OPEN HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL - KALAMAZOO; 3800 e. centre ave.; portage MI 49002
• MDR Report Key: 4833552
• MDR Text Key: 5906226
• Report Number: 4833552
• Device Sequence Number: 1
• Product Code: FMS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 05/11/2015

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?: *
• Device Operator: Invalid Data
• Device Model Number: CUB
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/11/2015
• Device Age: 6 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/10/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/11/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1