MAUDE Adverse Event Report: MAQUET (SUZHOU) CO.,LTD. ACROBAT SUV STABILIZER SYSTEM; STABILIZER, HEART

Model Number	ACROBAT-I STABILIZER Z
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that during preparation for a coronary artery bypass procedure using acrobat-i stabilizer.Whilst opening components it was discovered one of them was missing from the box.They believe the missing part is the actual stabilizer.
Additional Manufacturer Narrative
Trackwise id # (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 or Problem Description
N/a.
Additional Manufacturer Narrative
Trackwise id # (b)(4).Updated sections: g-4, g-7, h-2, h-6, h-10, h-11.Corrected sections: d-3, d-4, g-1 "contact office" & "contact person ¿ mfg site".The investigation has been started, since the complaint was received, and the following contents have been conducted: analysis of production: (3331/213 & 67) :the dhr of the reported lot 3000122814 has been reviewed.No non-conformity indicating the reported failure is observed.All the products had been performed 100% visual inspection during production.They all passed the inspection, which demonstrate that all devices are packaged inside the carton and no parts missing.Trend analysis: (4110/213 & 67) : in the last 12 months from 09th nov 2020 to 09th nov 2021, only this one case is received, the occurrence rate is approx.(b)(4).There¿s no similar complaint reported for this lot 3000122814.The labeling also has the warnings and precautions that ¿do not use if the product sterilization barrier or its packaging is compromised.¿ and the device missed was identified by customer before using, there was no patient involved.There were no consequences or impacts to the patient as there was no patient involvement.Historical data analysis: (4109/213 & 67): the review of the historical data indicates that no other similar complaints was reported for the same lot number and reported failure mode.Communication/interviews: (4111/213 & 67): communication/interviews were performed to obtain all possible information.Device not returned: (4114/ 3221 & 67): the device was not received, no returned product evaluation could be conducted.From the photos which were taken from another part in box they had on site, it is confirmed to be a stabilizer with labeling batch 3000122814.

• Brand Name: ACROBAT SUV STABILIZER SYSTEM
• Common Device Name: STABILIZER, HEART
• Manufacturer (Section D): MAQUET (SUZHOU) CO.,LTD.; no.158 fang zhou road; suzhou industrial park; suzhou NJ
• Manufacturer (Section G): MAQUET (SUZHOU) CO.,LTD.; no.158 fang zhou road; suzhou industrial park; suzhou NJ
• Manufacturer Contact: wendy zhou ; no.158 fang zhou road; suzhou industrial park; suzhou, NJ
• MDR Report Key: 12909653
• Report Number: 2242352-2021-01003
• Device Sequence Number: 5120654
• Product Code: MWS
• UDI-Device Identifier: 00607567900004
• UDI-Public: 00607567900004
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/07/2022
• Device Model Number: ACROBAT-I STABILIZER Z
• Device Catalogue Number: OM-9000Z
• Device Lot Number: 3000122814
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2021
• Supplement Date Received by Manufacturer: 02/02/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 02/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown