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

Model Number 70104.0852

Device Problem Device Inoperable (1663)

Patient Problem No Information (3190)

Event Type  malfunction  

Event Description

On (b)(6) 2013, the maquet sales and service unit (ssu) technician reported a problem with bmu-40 serial number (sn): (b)(4).According to the information provided by the customer to the ssu, the problem is with arterial measuring (arterial probe).Additionally, the values are not correctly and sometimes is on the display error message: "arterial probe disconnected".The ssu reviewed the log file and identified error code: 5029, sub:4165, which occurred on (b)(6) 2013.The ssu noted that the arterial board was replaced 4 months ago and now the error has reoccurred.This unit is at institute of clinical and experimentation medicine.

Manufacturer Narrative

(b)(4).Service report (b)(4) was generated for this repair.Per service report, the ir window was replaced.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: 4280522
• MDR Text Key: 5230646
• Report Number: 8010762-2014-00744
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: EZ
• 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: 03/12/2013

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: Other Health Care 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
• Distributor Facility Aware Date: 03/12/2013
• Device Age: 14 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/12/2013
• Initial Date Manufacturer Received: 03/12/2013
• Initial Date FDA Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2012
• 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