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

Model Number MODEL 100

Device Problems Display Difficult to Read (1181); Display or Visual Feedback Problem (1184); Visual Prompts will not Clear (2281)

Patient Problem No Patient Involvement (2645)

Event Date 06/05/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (serial #(b)(4)) displayed "system error, out of service, revert to manual cpr" error message during power on was confirmed during functional test and archive data review.The probable root cause of the system error was due to defective processor board, likely due to defective component.The reported complaint of a flickering lcd display on the platform was not confirmed during functional testing.The lcd display worked without any issue and passed all the functional check.No physical damage was observed on the returned autopulse platform during visual inspection.During archive data review, system error 132 - internal watchdog timeout was observed on (b)(6) 2020, thus confirming the reported complaint.During the initial functional test, returned autopulse platform displayed "system error, out of service, revert to manual cpr" during power on.To remedy the system error, the defective processor board was replaced.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 and it is ready for clinical use.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

During shift check, customer reported that the lcd was flickering and unreadable on the autopulse platform (serial #(b)(4)).Customer reinstalled the autopulse li-ion battery and platform worked as expected.Per customer, the lcd issue happened twice within 2 weeks.Before sending the platform for evaluation, the platform displayed "system error, out of service, revert to manual cpr ".No patient involvement.

• 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: 10261501
• MDR Text Key: 198783572
• Report Number: 3010617000-2020-00686
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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: 07/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• 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: 06/23/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/11/2018
• 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