MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
During device check, the demo autopulse platform (sn: (b)(4)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message.As reported, the ua07 error was a reoccurring issue with the autopulse platform.No patient involvement.
Additional Manufacturer Narrative
The reported complaint of "the autopulse platform (sn: (b)(6)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message" was confirmed based on the archive data review and during functional testing.The root cause of the reported complaint was the defective load cell module 2.The damaged covers and defective load cell module were likely attributed to mishandling such as a drop.Visual inspection of the returned platform was performed.The front enclosure and top cover were observed to be cracked.In addition, the load plate cover was observed to be torn, and the battery lock was noted to be bent.The observed physical damages were unrelated to the reported complaint and were appeared to be the characteristics of harsh impact as a result of user mishandling.All the damaged parts will be replaced to address the issues.A review of the archive data was performed and showed multiple user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error messages to have occurred around the customer's reported event date; thus, confirming the reported complaint.Unable to perform initial functional testing due to ua07 error message displayed upon powering up the platform; thus, confirming the reported complaint.Load cell characterization results confirmed that load cell 2 over-reported, and it will be replaced to remedy the fault.Unrelated to the reported complaint, it was noted that the backlight of the lcd was not lighting up; however, the lcd was still readable.The root cause was the defective processor board, likely as a result of normal wear and tear.Autopulse platform is a reusable device and was manufactured in september 2013, and it is over 7 years old, well beyond its expected service life of 5 years.The processor board will be replaced to remedy the issue.During further functional testing, it was noted that encoder driveshaft was stiff and could not rotate smoothly, unrelated to the reported complaint.The root cause was due to the sticky driveshaft clutch area, which is usually caused by sharp edges from all 12-hex edges of the armature plate or due to burrs on the surface of the clutch rotor, attributed to normal wear and tear and/or use of the device.Deburring/filing of the clutch plate will be performed to remedy the problem.Awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse platform with serial number (b)(6).
Additional Manufacturer Narrative
This supplemental mdr was created to retract the submitted mdr, as the autopulse platform (sn: (b)(6)) was a demo device and was not used on a patient.Therefore, this event is a non-complaint.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 10702339
• Report Number: 3010617000-2020-01035
• Device Sequence Number: 1138856
• Product Code: DRM
• UDI-Device Identifier: 00849111001090
• UDI-Public: 00849111001090
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/06/2023

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 Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 09/25/2020
• Supplement Date Received by Manufacturer: 11/10/2020; 07/06/2023
• Initial Report FDA Received Date: 10/19/2020
• Supplement Report FDA Received Date: 12/03/2020; 07/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/27/2013
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown