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	08/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the autopulse platform in complaint for investigation.A follow-up report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
During shift check, the autopulse platform (s/n (b)(4)) displayed "system error, out of service, revert to manual cpr" upon powering up.No patient involvement.
Additional Manufacturer Narrative
H4 (device manufacture date) was corrected.The reported complaint that "the autopulse platform (s/n (b)(6) ) displayed 'system error, out of service, revert to manual cpr' upon powering up" was confirmed during the archive data review and functional testing.The root cause of the reported complaint was the defective processor board due to a defective component, possibly caused by the fluid ingress observed inside the autopulse platform.During visual inspection, no physical damage was observed.During open case inspection, the bottom enclosures were removed, and fluid ingress was found inside the autopulse platform, unrelated to the reported complaint and attributed to user mishandling.The contamination had formed significant corrosion on the top cover metalized inner surface.Replacement of the top cover and complete reassembly of the platform will be needed to address the issue.Subsequently, the autopulse platform will be bio-cleaned.Archive data review showed system error, user advisory (ua) 136 (internal parameter corrupted); thus, confirming the reported complaint.Further review of the archive data showed multiple user advisory (ua) 46 (software error) occurred before and after the reported system error, unrelated to the reported complaint.The device firmware was likely corrupted as a result of the fluid ingress observed in the platform case, causing the intermittent occurrences of the ua46 advisory messages.The autopulse firmware must be reloaded to address the fault.The autopulse platform failed initial functional testing due to the "system error, out of service, revert to manual cpr" error message displayed upon powering up the device; thus, confirming the reported complaint.In addition, during the power-on self-test, it was noted that parameters in backup memory (non-volatile ram) had been corrupted.The root cause was the defective processor board, and it needs to be replaced to remedy the faults.During further functional testing, it was noted that the encoder driveshaft could not rotate smoothly, exhibiting binding and resistance, unrelated to the system error.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.The impact of the sticky clutch was not severe enough to make the platform non-functional.The issue may be resolved by deburring the clutch plate.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 complaints reported for autopulse platform with serial number (b)(6).

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 12485139
• Report Number: 3010617000-2021-00861
• Device Sequence Number: 3834403
• Product Code: DRM
• UDI-Device Identifier: 00849111002530
• UDI-Public: 00849111002530
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2021

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: 8700-0740-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2021
• Initial Date Received by Manufacturer: 08/22/2021
• Supplement Date Received by Manufacturer: 09/20/2021
• Initial Report FDA Received Date: 09/16/2021
• Supplement Report FDA Received Date: 09/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1