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

Catalog Number FL19H

Device Problems Device Operates Differently Than Expected (2913); Fail-Safe Problem (2936)

Patient Problem Swelling (2091)

Event Date 10/01/2017

Event Type  malfunction  

Manufacturer Narrative

User facility report # (b)(4).The user facility indicated that they evaluated the device and did not find any problems with functionality and declined to have a stryker representative evaluate the device.The user facility reported that two bags belonging to the parents of the patient were hanging on the foot rail handle.One of the bags was said to be a heavy bag of books.The user facility believes the bags that were hanging on the siderail handle allowed for the handle to rotate, and they have stated they are no longer allowing use of the bed handles as hanging places.Declined by user facility.

Event Description

It was reported by user facility medwatch that a (b)(6) patient was alone in a hospital room in a cub crib for approximately 15 minutes.The nurse reported all of the siderails were up.However, when the nurse returned to the room, the patient was not in the cub crib.The patient was standing at the foot of the crib and the railing of the crib was partially down.The patient reportedly had a bump on her head.A ct scan was administered and the results were negative.

Manufacturer Narrative

Supplemental submitted to include udi.Declined by user facility.

Event Description

It was reported by user facility medwatch that a (b)(6) old patient was alone in a hospital room in a cub crib for approximately 15 minutes.The nurse reported all of the siderails were up.However, when the nurse returned to the room, the patient was not in the cub crib.The patient was standing at the foot of the crib and the railing of the crib was partially down.The patient reportedly had a bump on her head.A ct scan was administered and the results were negative.

• 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: kristen canter ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 7217519
• MDR Text Key: 98297322
• Report Number: 0001831750-2018-00057
• 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,Followup
• Report Date: 03/26/2018

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?: Yes
• Device Operator: No Information
• Device Catalogue Number: FL19H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/02/2018
• Initial Date FDA Received: 01/24/2018
• Supplement Dates Manufacturer Received: 01/02/2018
• Supplement Dates FDA Received: 03/26/2018
• Was Device Evaluated by Manufacturer?: No
• 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