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 Patient Involvement (2645)
Date of Event	06/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned and investigation has been completed.
Event or Problem Description
When the customer was testing the autopulse platform (sn: (b)(4)), the platform displayed "system error, out of service, revert to manual cpr" error message.No patient involvement.
Additional Manufacturer Narrative
The reported complaint of the autopulse platform (sn: (b)(6) displayed "system error, out of service, revert to manual cpr" error message was confirmed during the archive data review and functional testing.The root cause of the reported complaint was a defective processor board as a result of normal wear and tear.The autopulse platform is a reusable device and was manufactured in april 2008, and it is over 12 years old, well beyond its expected service life of 5 years.During visual inspection of the returned platform, it was observed that the head restraint wires were broken off and detached from the top cover.Also, the front enclosure was observed scratched, and there was a vertical crack running through one of the screw fittings.In addition, the battery lock was observed bent.The physical damages were unrelated to the reported complaint and appeared to be the characteristics of normal wear and tear and/or user mishandling.The top cover, front enclosure, and the battery lock will be replaced to address the observed issues.The archive data could not be downloaded due to the defective processor board.However, the platform and interfacing pc were able to communicate, and therefore, the archive data was reviewed and showed system error, user advisory (ua) 136 (internal parameter corrupted); thus, confirming the reported complaint.During functional testing, upon powering up the platform, the "system error, out of service, revert to manual cpr" error message was displayed.Therefore, the reported complaint was confirmed, and the root cause was determined to be the defective processor board, which will be replaced to remedy the fault.Awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for autopulse 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
• MDR Report Key: 10213613
• Report Number: 3010617000-2020-00639
• Device Sequence Number: 2641327
• Product Code: DRM
• UDI-Device Identifier: 00849111000116
• UDI-Public: 00849111000116
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2020

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: 8700-0700-02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/25/2020
• Initial Date Received by Manufacturer: 06/09/2020
• Supplement Date Received by Manufacturer: 07/03/2020
• Initial Report FDA Received Date: 06/30/2020
• Supplement Report FDA Received Date: 07/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1