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

Catalog Number FL19H

Device Problem Insufficient Information (3190)

Patient Problem Fall (1848)

Event Date 12/08/2017

Event Type  Injury  

Manufacturer Narrative

Feedback was provided to the hospital that the canopy should be locked into position.

Event Description

It was reported that a child fell out of a cub crib.It was stated by the patient safety specialist at the hospital that the siderails were reported to be up at the time of the alleged event and the top cover was down.A nurse nearby had heard a sound and found that the child had fallen out of the crib.The child reportedly was given a "c-spine" x-ray which came back clear and was monitored overnight due to the height of the fall.The child did not experience any adverse consequences and was released without treatment after monitoring overnight.It was further reported by the user facility that it is believed that the top canopy was not locked into place and the child may have pushed it out of the way.

• Brand Name: CUB PEDIATRIC CRIB- HYD BASE
• Type of Device: BED, PEDIATRIC OPEN HOSPITAL
• Manufacturer (Section D): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer (Section G): STRYKER MEDICAL-KALAMAZOO; 3800 east centre avenue; portage MI 49002
• Manufacturer Contact: mary klaver ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7168728
• MDR Text Key: 96518821
• Report Number: 0001831750-2018-00018
• Device Sequence Number: 1
• Product Code: FMS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: FL19H
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 12/08/2017
• Initial Date FDA Received: 01/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/03/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1