MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Patient Involvement (2645)

Event Date 06/24/2020

Event Type  malfunction  

Manufacturer Narrative

On june 24, 2020, the autopulse platform (serial #(b)(4)) was serviced for preventive maintenance (pm).During the functional testing, the autopulse platform displayed user advisory user advisory "(ua)17" (max motor on time exceeded) and "fault code16" (timeout moving to take-up position) error messages.The root cause of "(ua)17" and "fault code16" was due to damaged drive train motor, likely attributed to wear and tear.The autopulse platform was manufactured in november 2015 and is nearing its expected serviceable life of 5 years.The drive train motor assembly was replaced to remedy these uas.Also, the archive data could not be download and load cell characterization test could not be performed due defective processor board, a capacitor was broken on the main board, likely the capacitor over-heated and over time the leg became fragile leading to the breakage.The processor board was replaced, and load cell characterization test passed and archive can be downloaded with no data since it a newly installed component.No physical damage was observed on the returned autopulse platform during visual inspection.After service completion, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test battery until discharged without any fault or error.The autopulse platform passed all functional tests.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 Description

On june 24, 2020, during preventive maintenance (pm), the autopulse platform (serial # (b)(4)) displayed user advisory "(ua)17" (max motor on time exceeded) and fault code16 (timeout moving to take-up position) error messages during initial functional testing.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, ca ; 4192922
• MDR Report Key: 10299507
• MDR Text Key: 199712426
• Report Number: 3010617000-2020-00728
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1