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

Model Number MODEL 100

Device Problem Failure to Power Up (1476)

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

Event Type  malfunction  

Event Description

The autopulse platform (sn (b)(6)) was used to resuscitate a patient.The platform functioned as intended during the resuscitation, and the resuscitation was completed.However, the customer mentioned that the patient's body fluids (blood) probably got inside the autopulse platform.After the resuscitation, the customer cleaned the autopulse platform using disinfectant wipes, and the autopulse platform did not power up after cleaning.No consequences or impacts on the patient.

Manufacturer Narrative

The customer's complaint that the autopulse platform (sn (b)(6)) did not power up was not confirmed during the functional testing.The autopulse platform could be powered on and passed the functional testing without fault or error.Upon visual inspection, no physical damage was observed.The archive data indicated no significant discrepancies.The autopulse platform passed the functional testing without fault or error, not confirming the reported complaint.A load cell characterization test confirmed that both cell modules function within the specification, and the brake gap inspection was performed and verified the brake gap was within the specification.During further inspection and upon removing the top cover, severe corrosion on the inside of the upper part of the housing and the drive train motor mount was noted.Also, the processor board, power supply & interface board had traces of body fluid, as mentioned by the customer that the patient's body fluids (blood) probably got inside the autopulse platform.The top cover, motor mount, circuit boards, and connection cables need to be replaced to address the observed corrosion.The observed corrosion and traces did not affect the functionality of the autopulse platform.Zoll is awaiting customer approval for service repair.

• 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: 18378723
• MDR Text Key: 331224627
• Report Number: 3010617000-2023-01047
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2023
• 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: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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