MAUDE Adverse Event Report: STRYKER CUB; PEDIATRIC CRIB

Device Problems Unstable (1667); Unintended Movement (3026)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/19/2017

Event Type  Injury  

Event Description

Railing of stryker cup pediatric crib came down when child placed her weight on the railing.The railing was believed to be in the full up position and locked.It was noted that the child's parent had hung two bags full of heavy books on the actuating handle of the railing that came down.Post event another same crib type was tested with a 25 lb weight hung from the handle was noted to be partially displaced in the direction, it would move if the handle was being used to unlock the railing.

• Brand Name: CUB
• Type of Device: PEDIATRIC CRIB
• Manufacturer (Section D): STRYKER
• MDR Report Key: 7145519
• MDR Text Key: 95827901
• Report Number: MW5074217
• Device Sequence Number: 2
• Product Code: FMS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Caregivers
• Type of Report: Initial
• Report Date: 12/21/2017
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention