MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO-U; VENTILATOR, CONTINUOUS, FACILITY USE

Model Number SERVO-U

Device Problem Pressure Problem (3012)

Patient Problem Injury (2348)

Event Type  Injury  

Event Description

According to a blog publication, a patient in icu for 8 months was on occasions treated with nava.In the blog it is alleged that the patient could have taken bigger breaths causing her diaphragm to have a greater contraction, leading to high inspiratory pressures and high volumes causing damage and inflammation to her lungs.The family requested discontinuation of life support and the patient was let pass away after bringing her home.No indication of a product malfunction.Manufacturer ref #: (b)(4).

Manufacturer Narrative

The hospital had no additional information to provide in the matter.There was no complaint submitted by the hospital.The information available was therefore the blog narrative.According to the blog narrative, the patient was in icu for 8 months and treated with ventilatory therapy in various ventilation modes that also included the nava (neurally adjusted ventilatory assist) mode of ventilation.The narrative does not specify given ventilation periods in the various ventilations modes and their resulting effectiveness covering the entire period of 8 months.According to the narrative, there were many issues with patient during the 8 months resulting in administration with many different types of medications, sedations and cpr among others.The allegation that the patient could have taken bigger breaths causing her diaphragm to have a greater contraction, leading to high inspiratory pressures and high volumes causing damage and inflammation to her lungs with the available information cannot be confirmed.Ventilatory patient treatment is done by healthcare professionals who continuously adapt the ventilator¿s modes of ventilation, parameter settings and alarm limits according to the patient needs during treatment.There is nothing in the narrative that indicate any ventilator malfunction during the 8 months treatment.On the contrary the narrative states that the all the doctors¿ assessments of the case found no cause.There is nothing in the narrative that indicate any ventilator malfunction during the 8 months treatment.On the contrary the narrative states that the all the doctors¿ assessments of the case found no cause.H3 other text : no further information received.

Event Description

Manufacturer's ref.#: (b)(4).

• Brand Name: SERVO-U
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer (Section G): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• Manufacturer Contact: sara soderholm roman ; roentgenvagen 2; solna
• MDR Report Key: 9239467
• MDR Text Key: 177788099
• Report Number: 3013876692-2019-00027
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/07/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: SERVO-U
• Device Catalogue Number: 6694800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/07/2021
• Distributor Facility Aware Date: 12/06/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/07/2021
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/25/2019
• Supplement Dates Manufacturer Received: 12/06/2021
• Supplement Dates FDA Received: 12/07/2021
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 8 MO
• Patient Sex: Female
• Patient Weight: 1 KG