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

Model Number SERVO-U

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pneumothorax (2012)

Event Type  Injury  

Event Description

It was reported that during patient treatment in non-invasive nava mode of ventilation, an x-ray was performed and a pneumothorax was found.The pneumothorax required needle aspiration.The patient did not decompensate due to the pneumothorax.Final patient outcome was no injury.Manufacturer's ref #: (b)(4).

Manufacturer Narrative

No service was requested by the user facility and no parts have been returned.It is unknown from which batch the edi catheter came from.According to the user facility, neither the ventilator nor the chosen ventilation mode caused the event of pneumothorax.It is believed that the patient was surfactant deficient which led to the pneumothorax.The patient is doing well and remain in the nicu for prematurity but are not in need of respiratory support.The root cause of the reported event was by the user facility determined as patient related.There are no indications of ventilator malfunction.H3 other text : 4117.

Event Description

Manufacturer's ref #: 358979.

• Brand Name: SERVO-U/N
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 10476306
• MDR Text Key: 205097319
• Report Number: 3013876692-2020-00044
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SERVO-U
• Device Catalogue Number: 6694800
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/08/2020
• Distributor Facility Aware Date: 08/26/2020
• Device Age: 20 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/08/2020
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening