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

Model Number MODEL 100

Device Problems No Display/Image (1183); Use of Device Problem (1670)

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

Event Date 11/02/2023

Event Type  malfunction  

Manufacturer Narrative

The customer's complaint that the lcd screen of the autopulse platform (b)(6) was blank and could not perform compressions upon powering up was confirmed during the functional testing.The root cause of the reported complaint was a failed processor pca board, which is likely attributed to the device's aging.The autopulse platform was manufactured in 2013 and is over ten years old, well past the expected serviceable life of five years.Upon visual inspection, no physical damage was observed.The archive data could not be downloaded due to the device failing the initialization (power on self-test).Unable to perform functional testing due to the autopulse platform failed to power on.The technical investigation revealed the root cause of the observed and reported problem as a failed processor pca board.The processor pca assembly was replaced to address the reported complaint.Upon part replacement, the autopulse platform was subjected to a run-in test using a 95% large resuscitation test fixture (lrtf), and it passed without fault or error.Following service, the brake gap inspection was performed, and the brake gap was verified to be within the specification.The autopulse platform passed the run-in and final tests without 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 sn (b)(6).

Event Description

During a routine shift check using a cpr manikin, the lcd screen of the autopulse platform (b)(6) was blank and could not perform compressions upon powering up.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: 18253152
• MDR Text Key: 329710413
• Report Number: 3010617000-2023-00994
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 12/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2023
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/05/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2013
• 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