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

Catalog Number	FL19H
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Codes	Fall (1848); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This record is a consolidation of records summarized as part of the fda voluntary malfunction summary reporting program.12 devices were functionally/visually inspected in the field.The devices were repaired and returned to use.2 devices are pending evaluation.There was no remedial action taken.This device is not labeled for single use.
Event or Problem Description
This report summarizes 14 malfunction events, where it was reported the devices experienced end/siderail cannot latch upright, mid-position, access door unexpectedly opens, access door - wont latch/lock, or stuck at lowest height or false latch of siderail.There was 1 event with patient involvement with a fall; no adverse consequence or clinically relevant delay in treatment was reported.
Additional Manufacturer Narrative
1 device that was pending evaluation was evaluated in the field and the issue was confirmed.The device was repaired on site and returned to service.The device that was pending evaluation was not made available by the customer; the reported issue was not confirmed.Section h codes have been updated to reflect this.
Event or Problem Description
No new information.
Additional Manufacturer Narrative
An additional event was identified and therefore added to this summary report.
Event or Problem Description
This report now summarizes 15 malfunction event(s), instead of 14.

• Brand Name: CUB PEDIATRIC CRIB- HYD BASE
• Common Device Name: 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: melissa simon ; 3800 east centre avenue; portage, MI 49002 ; 2693292100
• MDR Report Key: 21925660
• Report Number: 0001831750-2025-00662
• Device Sequence Number: 4009330
• Product Code: FMS
• UDI-Device Identifier: 07613327169348
• UDI-Public: 07613327169348
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Exemption Number: VMSR
• Number of Events Summarized: 15
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/21/2025

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 Catalogue Number: FL19H
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/01/2025
• Supplement Date Received by Manufacturer: 04/01/2025; 04/01/2025
• Initial Report FDA Received Date: 04/29/2025
• Supplement Report FDA Received Date: 06/03/2025; 08/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown