MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/29/2024

Event Type  malfunction  

Event Description

During patient use, the autopulse platform (b)(6) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large).The crew re-started the autopulse platform, but the issue persisted.No consequences or impacts to the patient.

Manufacturer Narrative

The reported complaint that the autopulse platform (b)(6) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) was confirmed during both archive data review and functional testing.The root cause of the ua07 was the failed load cell #1.The broken covers and load cell failure were likely attributed to mishandling, such as a drop.Visual inspection showed that the front enclosure, top cover, and bottom enclosure were all damaged, unrelated to the reported complaint.Based on the photos provided by the zoll service team, the top cover had large cracks, a vertical line was going through one of the screw fittings of the front enclosure, and several of the screw bosses were broken on the bottom enclosure.These observed physical damages appeared as characteristic of harsh impacts due to user mishandling.All the damaged covers were replaced to address the observed issues.A review of the archive data showed multiple user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) around the customer's reported complaint date, confirming the reported complaint.Functional testing failed due to the ua07 advisory message displayed upon powering up the platform, confirming the reported complaint.A load cell characterization test confirmed that the root cause of the ua07 was the failed load cell #1, which was replaced.Subsequently, the autopulse platform passed a functional test using lrtf (large resuscitation test fixture) with known-good batteries for 15 minutes with no problem.Following service, a brake gap inspection was performed and verified the brake gap was within the specification.Another load cell characterization test was performed and confirmed that both cell modules were 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 no previous history of complaints reported for the autopulse platform with serial number (b)(6).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• 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 sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18964913
• MDR Text Key: 338428764
• Report Number: 3010617000-2024-00251
• 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
• Report Date: 03/22/2024

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: 03/06/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/17/2020
• 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