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)

Patient Problem No Patient Involvement (2645)

Event Date 07/24/2012

Event Type  malfunction  

Event Description

On (b)(6) 2012, blood monitoring unit (bmu) 40 with serial number (b)(4) at hospital (b)(6) gave a fail temperature probe arterial message when the device was turned on.According to the customer, the arterial probe was in place and clean when the device was turned on.Reference: complaint (b)(4).

Manufacturer Narrative

(b)(4).On (b)(6) 2012 service report (b)(4) was generated for the repair of this unit.Per service report , the arterial probe 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: 4280519
• MDR Text Key: 19303219
• Report Number: 8010762-2014-00741
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K090147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/30/2012

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
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/30/2012
• Initial Date Manufacturer Received: 07/30/2012
• Initial Date FDA Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2012
• 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