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

Model Number MODEL 100

Device Problem Unexpected Shutdown (4019)

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

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(6)) powered off after providing 18 minutes of compressions was not confirmed during the archive data review and functional testing.No malfunction was found during testing at zoll, and the autopulse platform functioned appropriately and as intended.During visual inspection, unrelated to the reported complaint, the front enclosure was observed damaged.The observed physical damage appeared to be the characteristic of user mishandling.In addition, unrelated to the reported complaint, the udi label was observed to be worn out.The observed issue was likely attributed to user mishandling or wear and tear.The autopulse platform was manufactured in june 2018 and is more than 5 years old.The front enclosure and udi label need to be replaced to address the issues.The archive data review showed no significant discrepancies.Based on the archive, unrelated to the reported complaint, four recent platform deployments were identified where the batteries had been replaced, yet the batteries still indicated two out of four power bars.All of these deployments concluded with normal exits.The autopulse platform passed the initial functional test without any fault or error.The customer reported complaint was not reproduced during the functional testing.The platform was tested with the large resuscitation test fixture (lrtf) with good known test batteries for 40 minutes without any fault or error.Waiting for customer approval for repair.B3, the date of event is unknown.

Event Description

During the patient call, the autopulse platform (sn (b)(6)) powered off after providing 18 minutes of compressions without displaying any user advisories.Manual cpr was performed for the rest of the call.No consequences or impact to the patient.Per the reporter, a fully charged autopulse li-ion battery was used.After the call, the platform was checked and was able to power on.Per the reporter, all batteries were successfully charged in the charger.

• 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18726903
• MDR Text Key: 335621247
• Report Number: 3010617000-2024-00148
• Device Sequence Number: 1
• Product Code: DRM
• 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: 02/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• 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: 02/13/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/29/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/06/2018
• 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