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

Catalog Number 6694800

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

Patient Problem Vomiting (2144)

Event Type  malfunction  

Event Description

During a post market interview, a nurse stated that on one occasion, active and passive drainage of a patient using an ng catheter was done prior to transporting of the patient.The patient however vomited out about 300 ml during transport.There was no patient harm reported.(b)(4).

Manufacturer Narrative

No parts have been investigated but the initial information that was received during the post-market interviews from the hospital indicated that it was unknown how many members of staff actually followed the hospitals' aspiration instructions and therefore, the hospital could not ascertain that all aspiration procedures were done in a uniform manner.The hospital brought the event to our knowledge much later after its occurrence, as a result, a follow-up of the event with the hospital was not possible.A follow-up with the hospital shows that no further cases have occurred but they did not state if there is better adherence to the hospitals' aspiration work instruction.The cause has not been determined but it could have been a combination of the method used and the ng tube.

Event Description

(b)(4).

• Brand Name: SERVO-U
• Type of Device: VENTILATOR, CONTINUOUS, FACILITY USE
• Manufacturer (Section D): MAQUET CRITICAL CARE AB; solna ; SW
• Manufacturer (Section G): MAGNUS LINDQVIST; maquet critical care ab; röntgenvägen 2, se-171 54; solna ; SW
• Manufacturer Contact: maquet critical care ab; röntgenvägen 2, se-171 54; solna
• MDR Report Key: 5973254
• MDR Text Key: 55729498
• Report Number: 8010042-2016-00440
• Device Sequence Number: 1
• Product Code: CBK
• Combination Product (y/n): N
• Reporter Country Code: SW
• PMA/PMN Number: K151814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/04/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2016
• 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