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

Model Number FL19H

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Abrasion (1689); Physical Entrapment (2327)

Event Date 01/01/2020

Event Type  malfunction  

Manufacturer Narrative

This mdr is part of the fda voluntary malfunction summary reporting program.One device was evaluated in the field but the issue was not confirmed; no defect or malfunction was found.One device is pending investigation.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 2 malfunction events, where it was reported the patient's finger was stuck in the device.One patient received an abrasion.Neither patient required medical intervention.

Manufacturer Narrative

The final device was evaluated in the field; no defect was found with the device that would cause or contribute to the reported event/malfunction.

Event Description

This report summarizes 2 malfunction events, where it was reported the patient's finger was stuck in the device.One patient received an abrasion.Neither patient required medical intervention.

• 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: 9638945
• MDR Text Key: 176867996
• Report Number: 0001831750-2020-00297
• 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: 2
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/19/2020

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/01/2020
• Initial Date FDA Received: 01/28/2020
• Supplement Dates Manufacturer Received: 01/01/2020
• Supplement Dates FDA Received: 03/19/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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