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

Model Number FL19H

Device Problem Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/25/2020

Event Type  malfunction  

Event Description

It was reported there was an unexpected drop/collapse of the siderail.There are no reports of patient involvement or adverse consequences.

• 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: kaitlyn matheny ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 11246183
• MDR Text Key: 229371486
• Report Number: 0001831750-2021-00425
• 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: 01/28/2021

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 Model Number: FL19H
• Device Catalogue Number: FL19H
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/08/2021
• Initial Date FDA Received: 01/28/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2008
• 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