MAUDE Adverse Event Report: MAQUET CARDIOVASCULAR LLC ACCESSRAIL PLATFORM (STANDARD BLADE); INSTRUMENTS, SURGICAL, CARDIOVASCULAR

Model Number	SB-1000
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The hospital reported that the sb-1000 standard blades malfunctioned and it wasn't working properly.No injury to the patient was reported.
Additional Manufacturer Narrative
Tw 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
The hospital reported that the sb-1000 standard blades (right) malfunctioned and it wasn't working proper.No injury to the patient was reported.
Additional Manufacturer Narrative
Trackwise # (b)(4).The lot # 3000293769 history record review was completed.There were ncmrs , rework, or deviations documented for the reported lot number.Based on the dhr/lhr review results, it was determined that there is no relation between the batch manufacturing process and the no specific failure mode.H3 other text : device not returned.

• Brand Name: ACCESSRAIL PLATFORM (STANDARD BLADE)
• Common Device Name: INSTRUMENTS, SURGICAL, CARDIOVASCULAR
• Manufacturer (Section D): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer (Section G): MAQUET CARDIOVASCULAR LLC; 45 barbour pond drive; wayne NJ
• Manufacturer Contact: arelean guzman ; 45 barbour pond drive; wayne, NJ
• MDR Report Key: 17396992
• Report Number: 2242352-2023-00607
• Device Sequence Number: 5931402
• Product Code: DWS
• UDI-Device Identifier: 00607567700215
• UDI-Public: 00607567700215
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2023

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: 01/29/2025
• Device Model Number: SB-1000
• Device Catalogue Number: SB-1000
• Device Lot Number: 3000293769
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 08/31/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNK.; UNKNOWN.
• Patient Sex: Unknown