MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ACROBAT-I STABLIZER

Model Number C-OM-10000

Device Problem Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/24/2015

Event Type  malfunction  

Event Description

The hospital reported that during a coronary artery bypass procedure, acrobat-i stabilizer did not have a lock lever on the mont.A replacement device was used to complete the procedure.The hospital did not report any patient effects.

Manufacturer Narrative

The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.A lot history record review was completed for the reported product lot number.There was no nonconformance recorded in the lot history.(b)(4).

Manufacturer Narrative

The device was returned to the factory for evaluation.No evidence of blood or clinical use was observed.A visual inspection was conducted.The cap on the locking lever was dislocated and was not returned.Based on the condition of the device as returned the reported complaint was confirmed.The device history record (hr) was reviewed.The records show the device lot conformed to all applicable specifications.The dhr is available for review as an attachment to the record.

• Brand Name: ACROBAT-I STABLIZER
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; wayne NJ
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4951786
• MDR Text Key: 16524177
• Report Number: 2242352-2015-00603
• Device Sequence Number: 1
• Product Code: DXC
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 06/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/16/2017
• Device Model Number: C-OM-10000
• Device Lot Number: 25110157
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1