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 Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/01/2020

Event Type  malfunction  

Manufacturer Narrative

This mdr is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.The devices were evaluated in the field and the issue was confirmed; 4 devices had broken/damaged components, 5 devices had alignment issues, and 1 device had a bent component.The devices were repaired and returned.1 device is pending evaluation.There was no remedial action taken.This device is not labeled for single use.

Event Description

This report summarizes 11 malfunction events, where it was reported the siderail couldn't latch or was stuck.There was no patient involvement.

Manufacturer Narrative

The final device was evaluated in the field and it was determined the issue was incorrectly reported; the issue was found to be a railing that was stuck in an upright position.B5 has been updated to reflect one fewer event experiencing the reportable issue.

Event Description

This report summarizes 10 malfunction events, where it was reported the siderail couldn't latch or was stuck.There was no patient involvement.

• 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: 10325664
• MDR Text Key: 200398308
• Report Number: 0001831750-2020-00866
• Device Sequence Number: 1
• Product Code: FMS
• UDI-Device Identifier: 07613327169348
• UDI-Public: 07613327169348
• Combination Product (y/n): N
• Number of Events Reported: 10
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

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
• Initial Date Manufacturer Received: 07/01/2020
• Initial Date FDA Received: 07/27/2020
• Supplement Dates Manufacturer Received: 07/01/2020
• Supplement Dates FDA Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1