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 Patient Involvement (2645)
Date of Event	01/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of "system error, out of service, revert to manual cpr" error message was confirmed based on the archive review and during functional testing.The fault was found to be due to the defective processor board.The platform failed the initial functional testing due to a system error, (latch error 136 - internal parameter corrupted) was observed upon powering up the device.As part of routine service during testing, the platform was examined and unrelated to the reported complaint, damaged motor cover, top cover and bay compartment were noted and encoder drive shaft does not rotate smoothly, exhibits binding and resistance.The autopulse platform is a reusable device as well as a serviceable device and was manufactured in december 2006 and is 12 years old, well beyond the expected service life of five years.Therefore, this type of physical damage is characteristic of normal wear and tear for the life of the device.A review of the archive was performed and the archive data shows system error 136 - internal parameter corrupted, thus confirming the reported complaint.Following the replacement of defective parts, the device was further tested and passed all testing criteria with no issues or faults observed.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)(4).
Event or Problem Description
As reported, during the device check, the autopulse platform (sn (b)(4)) displayed a system error, out of service, revert to manual cpr message on the display screen.No patient involvement.

• 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: 8291368
• Report Number: 3010617000-2019-00048
• Device Sequence Number: 2575703
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/30/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2019
• Initial Report FDA Received Date: 01/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1