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

Catalog Number FL19H

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Physical Entrapment (2327)

Event Date 03/30/2019

Event Type  malfunction  

Event Description

It was reported that a pediatric patient was in the crib with his parents in the room when he got his thumb entrapped in the canopy option assembly while it was in the raised position.It was reported that a lidocaine nerve block was done for the patient to keep him calm while his thumb was freed from the canopy option assembly.It was reported that it took approximately an hour for the bio-med department to cut away the assembly in order to free the patient's hand.

• 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: brian thompson ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 8569484
• MDR Text Key: 143947008
• Report Number: 0001831750-2019-00560
• Device Sequence Number: 1
• Product Code: FMS
• UDI-Device Identifier: 07613327169348
• UDI-Public: 07613327169348
• 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
• Report Date: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Catalogue Number: FL19H
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/09/2015
• 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