MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG MAQUET CARDIOPULMONARY AG

Model Number 70102.8580

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 05/18/2015

Event Type  malfunction  

Event Description

It was reported that customer stated the single pump would display an intermittent belt slip error that progressively got worse over time.Pump is used in a teaching class and not on any patients.Pump to be sent to the national repair center in (b)(4) for service.(b)(4).

Manufacturer Narrative

(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.

• 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: 4798447
• MDR Text Key: 5925088
• Report Number: 8010762-2015-00662
• 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: Study,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 70102.8580
• Device Catalogue Number: 70102.8580
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2009
• 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