MAUDE Adverse Event Report: DATEX-OHMEDA, INC. GIRAFFE IRS; VENTILATOR,EMERGENCY,(RESUSCITATOR)

Model Number	6600-1061-200
Medical Device Problem Code	Decrease in Pressure (1490)
Health Effect - Clinical Codes	Low Cardiac Output (2501); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Ge healthcare investigation into the reported occurrence is ongoing.A follow-up report will be issued when the investigation has been completed.Block a: patient information could not be obtained due to country privacy laws.Legal manufacturer: hcs research park: (b)(6).H3 other text: device evaluation anticipated, but not yet begun.
Event or Problem Description
The hospital reported that upon delivery, a fetus in a giraffe irs warmer had an initial heart rate of less than 60 and they initiated use of the integrated resuscitation device.The facility attempted to use a t-piece, but there was no chest rise.It appeared that there was a sudden loss of pressure from the device and that the peak inspiratory pressure (pip) was not adequate even though there was a good seal on the face mask.A larygeal (i-gel) was placed in conjunction with the t-piece providing chest rise.However, the heart rate remained less than 60.The infant was then intubated and transferred to the nicu.Infant blood gas upon arrival in nicu, revealed severe acidosis and moderate to severe hie (hypoxic-ischemic encephalopathy).Ge healthcare will submit a follow-up report when the investigation has been completed.
Additional Manufacturer Narrative
Ge healthcare's (gehc) investigation has been completed.Based on the investigation analysis, it can be concluded that there is no issue with the ires device.According to the information available, the resuscitation device did not malfunction as the resuscitation device provided pressure correctly after the clinician transitioned to the laryngeal (i-gel) airway.This indicated both the resuscitation device and the t-piece circuit were functioning correctly.Therefore, there are no indications a ge healthcare device caused or contributed to the event.The root cause is undetermined.
Additional Manufacturer Narrative
D4 primary udi number: this device was not manufactured for sale in the usa and therefore a usa udi is not available.
Additional Manufacturer Narrative
D4 primary udi number corrected.

• Brand Name: GIRAFFE IRS
• Common Device Name: VENTILATOR,EMERGENCY,(RESUSCITATOR)
• Manufacturer (Section D): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer (Section G): DATEX-OHMEDA, INC.; 3030 ohmeda dr,; madison, WI 53718
• Manufacturer Contact: anthony amenson ; 3030 ohmeda drive; madison, WI 53718
• MDR Report Key: 18408699
• Report Number: 2112667-2023-06938
• Device Sequence Number: 8660356
• Product Code: BTL
• UDI-Device Identifier: 00813841020010
• UDI-Public: (01)00813841020010
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K070210
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 09/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 6600-1061-200
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2023
• Supplement Date Received by Manufacturer: 01/29/2024; 05/29/2024; 05/29/2024
• Initial Report FDA Received Date: 12/28/2023
• Supplement Report FDA Received Date: 02/27/2024; 08/29/2024; 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2019
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown