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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

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

Event Date 11/13/2023

Event Type  malfunction  

Event Description

During shift check, the user noted that the multiple autopulse li-ion batteries keep getting stuck in the battery compartment of the autopulse platform (sn (b)(6)) and required excessive force to remove.No patient involvement.

Manufacturer Narrative

The customer reported a complaint that the autopulse li-ion batteries keep getting stuck in the battery compartment of the autopulse platform (sn (b)(6)) and required excessive force to remove was not confirmed during the functional testing.The autopulse li-ion batteries used during the reported event were not returned for investigation.The probable root cause of the reported complaint might be related to damaged battery guide pins or the battery connector.The customer reported complaint could not be reproduced during the testing using multiple good known autopulse li-ion batteries, and the autopulse platform functioned as intended.Upon visual inspection, unrelated to the reported complaint, a torn load plate cover that affects the watertight seal was observed, likely attributed to user mishandling.The load plate cover was replaced to address the observed physical damage.In addition, unrelated to the reported complaint, cracks in the screw well area of the front and bottom enclosures were noted.The root cause of the observed physical damages is likely attributed to user mishandling, such as a drop.The front and bottom enclosures were replaced to address the observed physical damages.The archive data review indicated no significant discrepancies.The autopulse platform passed the preliminary functional testing without fault or error.During further investigation, multiple batteries were inserted and removed without any issues.No visual damage was noted on the battery connector inside the battery bay of the autopulse platform.Following service, the autopulse platform passed the run-in and final tests without fault or error.

• 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: 18298389
• MDR Text Key: 330134471
• Report Number: 3010617000-2023-01040
• 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: 12/09/2023

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: 11/27/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/13/2023
• Initial Date FDA Received: 12/10/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/30/2022
• 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