MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BLOOD GAS MONITOR

Model Number BMU 40

Device Problem No Display/Image (1183)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/16/2015

Event Type  malfunction  

Event Description

According to the customer: "no po2 (oxygen partial pressure) readings." (b)(4).

Manufacturer Narrative

The product was not received for investigation of the manufacturer yet.The investigation is still pending.A supplemental medwatch will be submitted when further information becomes available.

Manufacturer Narrative

It was determined by maquet cardiopulmonary's service support that the arterial board and arterial probe are defective.This could be the most probable cause for the failure no po2 reading.The arterial board and probe were exchanged by maquet cardiopulmonary's service support.Afterwards the unit was tested for po2 measurement and was fully functional.

• Brand Name: BLOOD GAS MONITOR
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strabe 31; rastatt 76437 ; GM 76437 ; 2229321132
• MDR Report Key: 4768725
• MDR Text Key: 16307424
• Report Number: 8010762-2015-00440
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K090147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/16/2015

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: BMU 40
• Device Catalogue Number: 70104.0852
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/20/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2015
• Initial Date FDA Received: 05/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1