MAUDE Adverse Event Report: MAQUET CV ACROBAT-I POSITIONER; STABILIZER,HEART

Catalog Number C-XP-5000

Device Problem Device Operates Differently Than Expected (2913)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not yet been returned to maquet cardiac surgery for evaluation.We are following up with the customer for the return of the device.A supplemental report will be submitted if the device is received.

Event Description

The hospital reported that during a coronary artery bypass procedure, acrobat-i positioner tear down the muscles during positioning and the positioner were unstable to hold the apex and side of the heart, which experiences are very different from their many previous ones.The hospital did not report any patient effects.

Manufacturer Narrative

Internal complaint number: (b)(4).Autonumber # (b)(4).A lot history record review was completed for lots 25131773, 25131829, and 25130628 the last 3 lots shipped to the account prior to the aware date.There was no nonconformance which could be considered related to the reported event recorded in the lot history.

Event Description

The hospital reported that during a coronary artery bypass procedure, acrobat-i positioner tear down the muscles during positioning and the positioner were unstable to hold the apex and side of the heart, which experiences are very different from their many previous ones.The hospital did not report any patient effects.

• Brand Name: ACROBAT-I POSITIONER
• Type of Device: STABILIZER,HEART
• Manufacturer (Section D): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): MAQUET CV; 45 barbour pond drive; wayne NJ 07470
• Manufacturer Contact: 45 barbour pond drive; wayne, NJ 07470
• MDR Report Key: 6785734
• MDR Text Key: 82663771
• Report Number: 2242352-2017-00770
• Device Sequence Number: 1
• Product Code: MWS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-XP-5000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/02/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1