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

Catalog Number 6694800

Device Problem Material Discolored (1170)

Patient Problems Bradycardia (1751); Vomiting (2144)

Event Date 01/16/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that while the ventilator was connected to a patient, the patient began throwing up, was bradycardic and the breathing pattern became irregular.In an attempt to troubleshoot any mechanical problems, the ng tube for nava (neurally adjusted ventilatory assist) was removed from the patient.It was observed that the end of the ng tube for nava was black and the aspirate obtained before its removal had black flecks in it.The ng tube for nava had been in the patient for 4 days.Enteral feeds through the ng tube for nava were at 8ml of breast milk with no additives and no oral medicines passing through.There was no reported patient harm.(b)(4).

Manufacturer Narrative

Visual examination of the returned ng-tube for nava found that it was not swollen and had no cracks or showing any other signs of change in its size or material.There was no exfoliation but it was discolored from the distal end upwards for about 100 mm, the first 30 mm being more discolored.The discoloration was surficial.According to the information from the hospital there was no malfunctioning of the ng-tube for nava.The ng-tube functioned well during the entire time of 4 days when it was inserted.The concern was the discoloration that was noted after removal.The conclusion in the matter is that there was no ng-tube malfunction at any time.It was however discolored as reported.There is nothing to indicate a material change but the discoloration was surficial and very likely to patient¿s stomach content at the time.

Event Description

Manufacturer reference#: (b)(4).Importer reference #: (b)(4).

• Brand Name: SERVO-U
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• MDR Report Key: 8316599
• MDR Text Key: 136016449
• Report Number: 8010042-2019-00073
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K151814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6694800
• Was Device Available for Evaluation?: No
• Device Age: YR
• Date Manufacturer Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1