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

Model Number 70104.0852

Device Problems Device Operates Differently Than Expected (2913); Electrical Power Problem (2925)

Patient Problem No Patient Involvement (2645)

Event Date 02/20/2013

Event Type  malfunction  

Event Description

On (b)(6) 2013 the (b)(6) reported that the bmu-40 serial number(sn):(b)(4) would not turn on and the power distribution board showed all required voltages when off load.Reference: complaint (b)(4).

Manufacturer Narrative

Maquet medical system, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Service report (b)(4) was generated for this repair.Per service report, on (b)(4) 2013 the main board, arterial probe and battery kit were replaced.Device was tested per the service protocol and passed all tests.(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: 4280598
• MDR Text Key: 19351718
• Report Number: 8010762-2014-01010
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K090147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/28/2013

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: Health Professional
• Device Model Number: 70104.0852
• Device Catalogue Number: 70104.0852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2013
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/28/2013
• Device Age: 23 MO
• Event Location: Other
• Date Report to Manufacturer: 02/28/2013
• Initial Date Manufacturer Received: 02/28/2013
• Initial Date FDA Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2011
• 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