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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CRITICAL CARE AB SERVO GUARD FILTER
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MAQUET CRITICAL CARE AB SERVO GUARD FILTER Back to Search Results
Catalog Number 6595487
Device Problem Increase in Pressure (1491)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/30/2014
Event Type  malfunction  
Event Description
It was reported that while the ventilator was connected to a pt it alarmed for high peep (positive end expiratory pressure) and high pressure.After exchange of the filter the problem was solved.There was no pt harm.(b)(4).
 
Manufacturer Narrative
More info surrounding the event has been sought.A supplemental medwatch will be provided when investigation is finished.
 
Manufacturer Narrative
Additional information received from the hospital stated that the filter was a single use bi-directional bacterial/viral filter that had been in use for 19 hours.The customer further stated that during that time there were 3 nebulization periods with saline each lasting 30 minutes.The ventilator's logs were not received for evaluation but the filter was returned one month after the event for investigation.It was dry upon arrival and visual examination showed nothing unusual.The filter was tested for residue occlusion by connecting it in the patient circuit during ventilation.The filter was found functioning normally and it did not lead to increased resistance.There was no deviation in measured flow or pressure noted.The filter must be replaced every 24 hours.There are 2 related warnings in the ventilator's ifu.One is that the nebulizer should not be used without a filter connected to the expiratory inlet of the ventilator and the other that "during nebulization, carefully monitor the airway pressure.Increased airway pressure could result from a clogged filter.Replace the filter if the expiratory resistance increases or after 24 hours of use, whichever comes first".The conclusion in the matter is based on the reported alarms and the 3 nebulization periods that were performed is that the cause was due to a clogged filter.
 
Event Description
(b)(4).
 
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Brand Name
SERVO GUARD FILTER
Manufacturer (Section D)
MAQUET CRITICAL CARE AB
solna
SW 
Manufacturer Contact
magnus lindqvist
solna S-171- 54
SW   S-171 54
7307705
MDR Report Key4253383
MDR Text Key17276483
Report Number8010042-2014-00513
Device Sequence Number1
Product Code CAH
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K030071
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,User Facility,Distributor,distributor,forei
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 10/16/2014
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/12/2014
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number6595487
Was Device Available for Evaluation? Yes
Date Returned to Manufacturer11/03/2014
Is the Reporter a Health Professional? Yes
Date Manufacturer Received10/16/2014
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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