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

Catalog Number 6487800

Device Problem Use of Device Problem (1670)

Patient Problem Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

The complaint was reported long after its occurrence and therefore the investigation is based on the information that was received.The information about the reported incident was received by our field service engineer by the way during a service visit at the hospital.The reported event occurred in 2013 or 2014.The patient had both the ng tube for nava and a nasogastric tube inserted at the time of the event and it was not determined if the perforation was caused by the ng tube for nava or the nasogastric tube.No further information is available.There is adequate information in the user¿s manual for calculating of the insertion length and correct positioning of the edi catheter and important information stating that when the ng tube for nava is inserted into the esophagus does not insert any other probe or feeding tube.With the limited information available the cause of the reported incident cannot be determined.(b)(4).

Event Description

It was reported that the nasogastric (ng) tube for nava (neurally adjusted ventilatory assist) may have caused perforation in esophagus.The final patient outcome was no injury.Manufacturer reference # (b)(4).

• Brand Name: SERVO-I
• 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: roentgenvagen 2; solna
• MDR Report Key: 8635890
• MDR Text Key: 145927280
• Report Number: 8010042-2019-00340
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: FI
• PMA/PMN Number: K123149
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 6487800
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/03/2019
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening