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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 70104.0852
Device Problem Failure to Calibrate (2440)
Patient Problem No Patient Involvement (2645)
Event Date 07/22/2012
Event Type  malfunction  
Event Description
On (b)(6) 2013 the ssu at (b)(6) reported that the bmu-40 serial number(sn): (b)(4) was not able to be calibrated.(b)(4).
 
Manufacturer Narrative
(b)(4).Service report (b)(4) was generated for this repair.Per service report the arterial board was replaced and the software version was updated to 04.02.00.The unit was tested per the service protocol and passed all tests.(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 Key4280590
MDR Text Key5294106
Report Number8010762-2014-01013
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,Company Representative
Reporter Occupation Other
Type of Report Initial
Report Date 07/22/2012
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 Number70104.0852
Device Catalogue Number70104.0852
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2013
Was the Report Sent to FDA? No
Distributor Facility Aware Date07/22/2012
Device Age4 YR
Event Location Other
Date Report to Manufacturer07/22/2012
Initial Date Manufacturer Received 07/22/2012
Initial Date FDA Received11/26/2014
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/31/2009
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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