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 Consequences Or Impact To Patient (2199)
Date of Event	08/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
As reported, the autopulse platform (sn (b)(4)) displayed "system error, out of service, revert to manual cpr" error message.No additional information was provided.No known impact or consequence to patient information was available.
Additional Manufacturer Narrative
The reported complaint of "system error, out of service, revert to manual cpr" error message was confirmed during functional testing and archive review.The root cause is due to a defective processor board likely due to aging.The autopulse platform is a reusable device and was manufactured in august 2006 and is 13 years old, well beyond the expected service life of five years.During functional testing, the platform failed due to a system error, (latch error 136 - internal parameter corrupted) was observed upon powering on the device.As part of routine service during testing, the platform was examined and unrelated to the reported complaint, damaged motor cover and battery bay compartment were observed.The motor cover and battery bay compartment need to be replaced to address the issue.This type of physical damage on the platform is likely attributed to wear and tear as a result of an aging device.A review of the archive was performed and the archive data shows error 136 (internal parameter corrupted), thus confirming the reported complaint.Upon customer approval, the damaged parts will be replaced.The console will be further tested to full specification.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform serial number (b)(4).

• 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: 8971331
• Report Number: 3010617000-2019-00768
• Device Sequence Number: 2585367
• 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,Followup
• Report Date (Section B): 10/18/2019

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2019
• Initial Date Received by Manufacturer: 08/14/2019
• Supplement Date Received by Manufacturer: 09/30/2019
• Initial Report FDA Received Date: 09/06/2019
• Supplement Report FDA Received Date: 10/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1