MAUDE Adverse Event Report: STRYKER CORP CUB PEDIATRIC CRIB

Model Number FL19H

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem Swelling (2091)

Event Date 10/24/2017

Event Type  malfunction  

Event Description

The primary nurse and na left the patient's room.All side rails on the crib were up.The patient's parents were not in the room.The primary nurse started her rounds approximately 15 minutes later and saw that the patient was not in her crib.Patient was found standing at the foot of the crib.The foot of the bed railing was partially down.The patient had a bump on her head.Ct scan was completed and was negative.Two bags belonging to the parents were hanging on the foot rail handle.They had been hanging dirty clothes there, as they had been staying in the room with the patient, but on this day, the parent's had hung other personal belongings, one of which was a heavy bag of books.We believe we recreated the event by hanging a 25 pound weight from one of the crib handles (pictures available).The handle rotated and likely decreased the locked position security.We are not certain at what minimum weight this inadvertent rotation can occur, or how potentially having bag straps or closure ropes wedged down behind the handle mechanism affects functionality of the locking mechanism.We will no longer allow use of the bed handles as hanging places.

• Brand Name: CUB PEDIATRIC CRIB
• Type of Device: PEDIATRIC CRIB
• Manufacturer (Section D): STRYKER CORP; 3800 e. centre ave.; portage MI 49002
• MDR Report Key: 7134320
• MDR Text Key: 95490282
• Report Number: 7134320
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FL19H
• Device Catalogue Number: FL19F/H (190)
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2017
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 2 YR
• Patient Weight: 9