CUB PEDIATRIC CRIB- HYD BASE FL19H

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative report with the FDA on 2019-04-30 for CUB PEDIATRIC CRIB- HYD BASE FL19H manufactured by Stryker Medical-kalamazoo.

Event Text Entries

[143584316] This mdr is part of the fda voluntary malfunction summary reporting program. The device was not evaluated, as the issue was identified upon receipt by the customer and the product was returned to the distribution center. There was no remedial action taken. This device is not labeled for single use.
Patient Sequence No: 1, Text Type: N, H10

[143584317] This report summarizes 1 malfunction event, where it was reported the brakes would not engage. There was no patient involvement.
Patient Sequence No: 1, Text Type: D, B5

MAUDE Entry Details

• Report Number: 0001831750-2019-00556
• MDR Report Key: 8565453
• Report Source: COMPANY REPRESENTATIVE
• Date Received: 2019-04-30
• Date of Report: 2019-04-30
• Date of Event: 2019-01-01
• Date Mfgr Received: 2019-04-01
• Date Added to Maude: 2019-04-30
• Event Key: 0
• Report Source Code: Manufacturer report
• Manufacturer Link: Y
• Number of Patients in Event: 0
• Adverse Event Flag: 3
• Product Problem Flag: 3
• Reprocessed and Reused Flag: 3
• Health Professional: 3
• Initial Report to FDA: 3
• Report to FDA: 3
• Event Location: 3
• Manufacturer Contact: MR. MARY KLAVER
• Manufacturer Street: 3800 EAST CENTRE AVENUE
• Manufacturer City: PORTAGE MI 49002
• Manufacturer Country: US
• Manufacturer Postal: 49002
• Manufacturer Phone: 2693292100
• Manufacturer G1: STRYKER MEDICAL-KALAMAZOO
• Manufacturer Street: 3800 EAST CENTRE AVENUE
• Manufacturer City: PORTAGE MI 49002
• Manufacturer Country: US
• Manufacturer Postal Code: 49002
• Single Use: 3
• Previous Use Code: 3
• Event Type: 3
• Type of Report: 3

Device Details

• Brand Name: CUB PEDIATRIC CRIB- HYD BASE
• Generic Name: BED, PEDIATRIC OPEN HOSPITAL
• Product Code: FMS
• Date Received: 2019-04-30
• Catalog Number: FL19H
• Device Availability: Y
• Device Eval'ed by Mfgr: N
• Device Sequence No: 1
• Device Event Key: 0
• Manufacturer: STRYKER MEDICAL-KALAMAZOO
• Manufacturer Address: 3800 EAST CENTRE AVENUE PORTAGE MI 49002 US 49002

Patients

Patient Number	Treatment	Outcome	Date
1	0		2019-04-30