MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET CARDIOPULMONARY AG

Model Number 70103.5075

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 06/22/2015

Event Type  malfunction  

Event Description

It was reported that customer stated belt slip alarm.No consequences to the patient.(b)(4).

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Maquet cardiopulmonary is aware of similar complaints from this product.Similar products, showing similar malfunction have tested.A supplemental medwatch will be submitted after receiving new information.

Manufacturer Narrative

Maquet cardiopulmonary is aware of similar complaints from this product.Similar products, showing similar malfunction, have tested.Customer stated the twin pump would display a belt slip message on screen prior to use.Service was called and evaluated the twin pump.Ran system at low and high rounds per minute with test tubing pack and no message or belt slip was displayed.Tested system to factory specifications.Tested ok.Thus failure cannot be confirmed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

(b)(4).

• Brand Name: MAQUET CARDIOPULMONARY AG
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer Contact: michael campbell ; kehler strasse 31; rastatt ; GM ; 2229321132
• MDR Report Key: 4914867
• MDR Text Key: 6027564
• Report Number: 8010762-2015-00800
• Device Sequence Number: 1
• Product Code: DPW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70103.5075
• Device Catalogue Number: 70103.5075
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2012
• 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