MAUDE Adverse Event Report: Critikon de Mexico S. de R.L. de C.V. Giraffe OmniBed Carestation; Incubator, Neonatal

Model Number	CS1
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2026
Type of Reportable Event	Malfunction

• Brand Name: Giraffe OmniBed Carestation
• Common Device Name: Incubator, Neonatal
• Manufacturer (Section D): Critikon de Mexico S. de R.L. de C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• Manufacturer (Section G): Critikon de Mexico S. de R.L. de C.V.; calle valle del cedro 1551; juarez 32575 ; MX 32575
• Manufacturer Contact: michaela moore ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 50142720
• Report Number: 3008729547-2026-00061
• Device Sequence Number: 10705604
• Product Code: FMZ
• UDI-Device Identifier: 00840682116862
• UDI-Public: (01)00840682116862(11)260211
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K213551
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2026

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
• Operator of Device: Health Professional
• Device Model Number: CS1
• Device Lot Number: AN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2026
• Supplement Date Received by Manufacturer: 10/01/2026
• Initial Report FDA Received Date: 08/05/2026
• Supplement Report FDA Received Date: 10/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2026
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown