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

Model Number MODEL 100

Device Problem Power Problem (3010)

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

Event Date 09/01/2023

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that "the autopulse platform (sn (b)(6)) would intermittently fail to power on and off when the on/off button was pressed" was not confirmed during the archive data review but was confirmed during functional testing.The root cause of the issue was a malfunctioning power switchboard that had rust and corrosion, leading to open/short circuits.This corrosion was likely caused by moisture ingress, attributed to user mishandling.Visual inspection revealed a few physical damages, unrelated to the reported complaint.A crack/breakage was observed near the front-end area of the front enclosure, and the bottom enclosure was chipped with multiple cracks in one of its screw bosses.These damages appeared to be characteristics of harsh impacts due to user mishandling, and the damaged enclosures were replaced.Review of the autopulse platform's archive data did not reveal any significant discrepancies or error messages.The autopulse platform passed the preliminary functional test without any issues.However, during further service evaluation, zoll service personnel noticed that the autopulse platform would power on intermittently when pressing the on/off button, confirming the customer's reported complaint.Troubleshooting the problem revealed that the power switchboard was not functioning as intended due to rust/corrosion, which had caused short circuits.The power switchboard was replaced to remedy the complaint.Following the replacement and service, the autopulse platform underwent run-in tests using the 95% large resuscitation test fixture (lrtf) with known-good test batteries until discharged, and it did not exhibit any faults or errors during this testing.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaint was found for the autopulse platform with sn (b)(6).

Event Description

During shift checks, the customer noticed the autopulse platform (sn (b)(6)) intermittently failed to power on when the on/off button was pressed.Per the customer, the platform was tested with fully charged (showing four solid green leds) batteries during the device checks.No patient involvement.

• 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 nguyen ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 17822389
• MDR Text Key: 324335171
• Report Number: 3010617000-2023-00816
• 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: 09/26/2023

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: 09/15/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2023
• Initial Date FDA Received: 09/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/28/2020
• 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