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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0 OXYGENATOR, CARDIOPULMONARY BYPASS

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MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0 OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
Device Problem Unable to Obtain Readings (1516)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/02/2021
Event Type  malfunction  
Manufacturer Narrative
Return of the involved product for investigation was requested but not yet received. A follow-up emdr will be submitted when additional information becomes available.
 
Event Description
The customer reported that during patient treatment the internal pressure was not measured. The hls set was connected to different cardiohelp units but the issue persisted. The pressure was then measured using an external sensor. Complaint id:(b)(4).
 
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Brand NameHLS SET ADVANCED 7.0
Type of DeviceOXYGENATOR, CARDIOPULMONARY BYPASS
Manufacturer (Section D)
MAQUET CARDIOPULMONARY GMBH
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Manufacturer (Section G)
JULIA KAPFENBERGER
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Manufacturer Contact
neue rottenburger strasse 37
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MDR Report Key12299049
MDR Text Key265758816
Report Number8010762-2021-00438
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 01/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberBEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
Device Catalogue Number701052794
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/30/2021
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? No
Type of Device Usage Unkown

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