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U.S. Department of Health and Human Services

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

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MAQUET CRITICAL CARE AB SERVO-U VENTILATOR, CONTINUOUS, FACILITY USE Back to Search Results
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).

 
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Brand NameSERVO-U
Type of DeviceVENTILATOR, 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 Key5973254
MDR Text Key55729498
Report Number8010042-2016-00440
Device Sequence Number1
Product Code CBK
Combination Product (Y/N)N
Reporter Country CodeSW
PMA/PMN NumberK151814
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/04/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/23/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number6694800
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/04/2016
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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