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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMOARY AG BLOOD MONITORING UNIT (BMU) 40; BLOOD GAS MONITOR
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MAQUET CARDIOPULMOARY AG BLOOD MONITORING UNIT (BMU) 40; BLOOD GAS MONITOR Back to Search Results
Model Number 7010.40852UL
Device Problem No Display/Image (1183)
Patient Problem No Patient Involvement (2645)
Event Date 03/15/2013
Event Type  malfunction  
Event Description
On (b)(6) 2013, at (b)(6) in (b)(6), it was reported that the display/screen on the bmu-40 serial number(sn): (b)(4) was defective.(b)(4).
 
Manufacturer Narrative
(b)(4).Service report (b)(4) was generated for this repair.Duration test was performed.Maintenance performed per the service protocol.(b)(4).
 
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Brand Name
BLOOD MONITORING UNIT (BMU) 40
Type of Device
BLOOD GAS MONITOR
Manufacturer (Section D)
MAQUET CARDIOPULMOARY AG
kehler strasse 31
rastatt, 7643 7
GM  76437
Manufacturer (Section G)
MAQUET CARDIOPULMOARY AG
kehler strasse 31
rastatt, 7643 7
GM   76437
Manufacturer Contact
tina evancho
45 barbour pond drive
wayne, NJ 07470
9737097265
MDR Report Key4280586
MDR Text Key5293580
Report Number8010762-2014-01012
Device Sequence Number1
Product Code DRY
Combination Product (y/n)N
Reporter Country CodeGM
PMA/PMN Number
K090147
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 03/15/2013
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number7010.40852UL
Device Catalogue Number7010.40852UL
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2013
Was the Report Sent to FDA? No
Distributor Facility Aware Date03/15/2013
Device Age5 YR
Event Location Hospital
Date Report to Manufacturer03/15/2013
Initial Date Manufacturer Received 03/15/2013
Initial Date FDA Received11/26/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2008
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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