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 Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/01/2020

Event Type  malfunction  

Manufacturer Narrative

This mdr is part of the fda voluntary malfunction summary reporting program.12 devices were evaluated in the field and the issue was confirmed; 7 devices had broken/damaged components, 3 devices had misaligned components, 3 devices had worn components and 1 device had a dirty component. the devices were repaired and returned.2 devices are pending evaluation.There was no remedial action taken. this device is not labeled for single use.

Event Description

This report summarizes 14 malfunction events, where it was reported the siderail could not latch/falsely latched.There was 1 instance with patient involvement; no adverse consequences were reported.

Event Description

This report summarizes 14 malfunction events, where it was reported the siderail could not latch/falsely latched.There was 1 instance with patient involvement; no adverse consequences were reported.

Manufacturer Narrative

It was originally reported that 2 devices were pending evaluation.This was not correct.The codes have been updated accordingly.

• 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
• MDR Report Key: 10748098
• MDR Text Key: 213455809
• Report Number: 0001831750-2020-01176
• Device Sequence Number: 1
• Product Code: FMS
• UDI-Device Identifier: 07613327169348
• UDI-Public: 07613327169348
• Combination Product (y/n): N
• Number of Events Reported: 14
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 01/19/2021

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: Health Professional
• Device Model Number: FL19H
• Device Catalogue Number: FL19H
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/01/2020
• Initial Date FDA Received: 10/28/2020
• Supplement Dates Manufacturer Received: 10/01/2020
• Supplement Dates FDA Received: 01/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1