MAUDE Adverse Event Report: MAQUET CARDIOPULMOARY AG BLOOD MONITORING UNIT (BMU) 40; BLOOD GAS MONITOR

Model Number 70104.0852

Device Problems Failure to Calibrate (2440); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

Blood monitoring unit (bmu) 40 with serial number (b)(4), at (b)(6), gave error code 05137 during self-testing, which occurs once the unit is initially powered on for use.The maquet sales and service unit technician replaced the arterial probe but the error remained.Reference: complaint (b)(4).

Manufacturer Narrative

(b)(4).Per service order (b)(4), the following components were replaced: batteries; rotary encoder; arterial probe; arterial board.Reference: complaint (b)(4).

• 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 Key: 4280513
• MDR Text Key: 20124445
• Report Number: 8010762-2014-00742
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K090147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/07/2012

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 Number: 70104.0852
• Device Catalogue Number: 70104.0852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 05/07/2012
• Initial Date Manufacturer Received: 05/07/2012
• Initial Date FDA Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1