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

Model Number 6487800

Device Problems No Audible Alarm (1019); Detachment of Device or Device Component (2907)

Patient Problem Apnea (1720)

Event Date 07/29/2018

Event Type  malfunction  

Event Description

The infant had an episode where the heartrate dropped into the 60's and oxygen saturations dropped into the 70%s.The staff noticed that the nasal intermittent positive pressure ventilation (nippv) prongs were out of the patient's nose.The prongs were placed back into the patient's nose, unwrapped, and stimulated the infant because apnea was noticed.Despite all interventions, the infant's vitals continued to trend downward so staff continued to give 100% fio2, sat up the infant, performed oral suction, and stimulated vigorously.At that time, oxygen saturation dropped to 0 and heart rate to 30.This lasted for approximately 5 seconds and the oxygen saturation increased to 16% and heart rate was 60-80 bpm.The staff got the bag and valve to start positive pressure ventilation (ppv).As they started to remove the nippv prongs from the infant's face to start administering ppv, they noticed that the prongs were not attached to the tubing connected to the ventilator.The ventilator did not alarm to alert staff to the disconnection as it usually does.The prongs were reconnected to the tubing that was attached to the ventilator.

• Brand Name: SERVO-I
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 7884732
• MDR Text Key: 120546168
• Report Number: 7884732
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/05/2018,08/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2018
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 6487800
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/05/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 42 DA