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 Insufficient Information (4580)

Event Date 12/07/2021

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on december 22, 2021 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

The customer reported that the autopulse platform (s/n (b)(4)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large).It is unknown where the problem occurred.However, patient use information was requested, but no additional information was provided.

Manufacturer Narrative

The reported complaint that "the autopulse platform (s/n (b)(6) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large)" was confirmed during functional testing and based on the review of the archive data.The root cause of the ua07 advisory message was the defective load cell 2.The broken enclosures and the defective load cell were likely attributed to mishandling such as a drop.During visual inspection, the front and bottom enclosures were observed damaged, unrelated to the reported complaint.Based on the photos provided by the zoll service team, vertical cracks and chips were going through the screw fittings of the enclosures.In addition, there were cracks and breakages in the interior of the bottom enclosure.The observed physical damages appeared to be the characteristics of harsh impacts due to user mishandling.The front and bottom enclosures were replaced to address the issues.Review of the archive data showed multiple ua07 advisory messages around the customer's reported event date; thus, confirming the reported complaint.Functional testing failed due to the ua07 advisory message displayed upon powering up the platform; thus, confirming the reported complaint.A load cell characterization test was performed and verified that load cell 2 was defective, and it was replaced to remedy the fault.Following service, a load cell characterization test was performed and confirmed both cell modules are functioning within the specification.The autopulse platform was subjected to a final run-in test using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there was one similar complaint reported for autopulse platform with serial number (b)(6).Ccr (b)(4) was reported on (b)(6) 2018, and the defective load cell was replaced to remedy the issue.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 13115370
• MDR Text Key: 283175452
• Report Number: 3010617000-2021-01229
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/13/2022

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
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/29/2021
• Supplement Dates Manufacturer Received: 01/10/2022
• Supplement Dates FDA Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2018
• 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