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

Model Number JH10.40852

Device Problems Loose or Intermittent Connection (1371); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 02/16/2012

Event Type  malfunction  

Event Description

On (b)(6) 2012, the ssu at maquet (b)(4) reported that the bmu-40 serial number(sn): (b)(4) made a rattling noise.It was also requested that safety testing and software update be performed on the device.Reference: complaint (b)(4).

Manufacturer Narrative

(b)(4).Service report (b)(4) was generated for this repair.Per service report, on (b)(6) 2012 the battery was replaced and loaded since the contact for the installed battery pack was loose.The pc board flashcard did not have contact.The main service software version 04.02.00 was installed.The unit was tested per the service protocol and passed all tests.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: 4280555
• MDR Text Key: 5231132
• Report Number: 8010762-2014-01004
• Device Sequence Number: 1
• Product Code: DRY
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K090147
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: JH10.40852
• Device Catalogue Number: JH10.40852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2012
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/21/2012
• Device Age: 3 YR
• Event Location: Other
• Date Report to Manufacturer: 02/21/2012
• Date Manufacturer Received: 02/21/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2009
• 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