MAUDE Adverse Event Report: STRYKER CORPORATION CUB; BED, PEDIATRIC OPEN HOSPITAL

Model Number FL19H

Device Problems Break (1069); Defective Component (2292)

Patient Problem Bone Fracture(s) (1870)

Event Date 10/04/2019

Event Type  malfunction  

Event Description

Newborn's parent was standing next to patient and siderail of crib broke, slamming down on the parent's finger.The parent suffered broken finger in 3 separate places as a result of a defective crib.The crib has been tagged as defective and removed from circulation.The parent was seen by local hospital for imaging and confirmed fracture via x-ray.Engineering inspected crib and found there is an internal cable/rope that helps to bring the side rail up and down.It appears that the rope snapped.Engineering was requested for testing/potential implications in other cribs.Engineering called vendor to understand how to inspect and predict when such a failure may occur and working to establish a testing procedure and long-term action plan moving forward.Stryker is opening up an incident investigation and a customer complaint for this event.Our local rep is engaging their quality and engineering departments to help us answer our questions and establish a game plan and we expect stryker to come onsite and work with us this week.

• Brand Name: CUB
• Type of Device: BED, PEDIATRIC OPEN HOSPITAL
• Manufacturer (Section D): STRYKER CORPORATION; stryker global headquarters; 2825 airview boulevard; kalamazoo MI 49002
• MDR Report Key: 9284235
• MDR Text Key: 165267665
• Report Number: 9284235
• Device Sequence Number: 1
• Product Code: FMS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: FL19H
• Device Catalogue Number: FL19H
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/31/2019
• Device Age: 8 YR
• Event Location: Hospital
• Date Report to Manufacturer: 11/06/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/06/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other