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

Catalog Number 6487800

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that during nava (neurally adjusted ventilatory assist) mode of ventilation, the ng-tube perforated the patient's stomach.Final patient outcome is unknown.(b)(4).

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).Exemption #: e2018003.Getinge usa sales, llc (b)(4).Further information regarding how correct positioning was ascertained was requested.The user facility has only responded that it was performed appropriately, but no further details or clarifications was provided.No x-rays were provided and no parts were returned for investigation.The conclusion in this matter is that there was no edi catheter malfunction or inadequate labeling/insertion/positioning information.The cause of the reported problem is attributed to user error or clinical application error.There is adequate information in the user¿s manual for calculating of the insertion length and correct positioning of the edi catheter.

• Brand Name: SERVO-I
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; roentgenvagen 2; solna
• MDR Report Key: 8519574
• MDR Text Key: 142113465
• Report Number: 8010042-2019-00266
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• PMA/PMN Number: K123149
• 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: 05/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 6487800
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 05/28/2019
• Date Manufacturer Received: 05/28/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening