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

Model Number FL19H

Device Problem Positioning Failure (1158)

Patient Problems Vertebral Fracture (4520); Insufficient Information (4580)

Event Date 04/18/2023

Event Type  Injury  

Event Description

It was reported that the access door on the siderail opened while the patient was getting into the bed and the patient fell.It was further reported that the patient sustained cracked ribs.The device was evaluated and no product problem was found.

Event Description

It was reported that the access door on the siderail opened while the patient was getting into the bed and the patient fell.It was further reported that the patient sustained cracked ribs and a wrist injury.The device was evaluated and no product problem was found.Treatment information could not be obtained.

Manufacturer Narrative

The device was evaluated and no product problem was found.Treatment information could not be obtained.

Manufacturer Narrative

It was further reported that there was also a wrist injury.

Event Description

It was reported that the access door on the siderail opened while the patient was getting into the bed and the patient fell.It was further reported that the patient sustained cracked ribs and a wrist injury.The device was evaluated and no product problem was found.

• 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: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 16846323
• MDR Text Key: 314313676
• Report Number: 0001831750-2023-00637
• 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,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: FL19H
• Device Catalogue Number: FL19H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/29/2015
• 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
• Patient Outcome(s): Other