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 Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of "the autopulse platform (sn (b)(4)) displayed "system error, out of service, revert to manual cpr" error message upon powering on" was confirmed during the functional testing.The root cause for the reported complaint was due to the defective processor board as a result of wear and tear of the autopulse platform.The autopulse platform is a reusable device and was manufactured in 2006 and is 13 years old, passed the expected service life of five years.Upon visual inspection, unrelated to the reported complaint, observed broken yellow bumpers.The cause for the physical damage was due to a normal wear and tear of the platform.The autopulse platform failed functional testing due to "system error, out of service, revert to manual cpr" error message displayed upon powering on.The archive data could not be downloaded due to the defective processor board.The service could not be performed due to the non-availability of the replacement part.The replacement part for autopulse 1.1 is no longer available.Informed customer about the non-availability of the parts and the autopulse platform will be returned to the customer with the sticker labeled 'not for clinical use".Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with serial number (b)(4).
Event or Problem Description
The autopulse platform displayed "system error, out of service, revert to manual cpr" error message upon powering on.No additional information was provided.No known impact or consequence to patient information was provided.

• 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: 9084810
• Report Number: 3010617000-2019-00812
• Device Sequence Number: 19497304
• Product Code: DRM
• UDI-Device Identifier: 00849111000314
• UDI-Public: 00849111000314
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/18/2019

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: 8700-0700-02-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1