MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE RESUSCITATION MODEL 100; 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 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
As part of routine service, the autopulse platform (sn (b)(4) was tested by the customer's biomed engineer and during functional testing displayed an error message "system error, out of service, revert to manual cpr" on the user control panel.No patient involvement.
Additional Manufacturer Narrative
The customer's 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 functional testing and based on the archive data review.The root cause for the system error was due to the defective processor board, as a result of normal wear and tear of the platform.The autopulse platform is a reusable device and was manufactured in january 2007 and is more than 13 years old, well beyond the expected service life of 5 years.There was no physical damage observed on the returned autopulse platform during visual inspection.The autopulse platform failed initial functional testing due to "system error, out of service, revert to manual cpr" error message displayed upon powering on.The archive data revealed latch error 136 - internal parameter corrupted, thus confirming the customer complaint.The defective processor board needs to be replaced to remedy the system error.Last autopulse 1.1 was manufactured in 2009.As of (b)(6) 2016, zoll announced the end of life for the autopulse 1.1.Many important components used in ap1.1 are no longer available further restricting our ability to service.Informed customer about the non-availability of the parts and the autopulse platform will be scrapped.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(6).

• Brand Name: AUTOPULSE RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 10709270
• Report Number: 3010617000-2020-01038
• Device Sequence Number: 3482820
• Product Code: DRM
• UDI-Device Identifier: 00849111000154
• UDI-Public: 00849111000154
• 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: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2020

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: 8700-0700-11
• 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: 11/11/2020
• Initial Report FDA Received Date: 10/20/2020
• Supplement Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1