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

Model Number MODEL 100

Device Problems No Display/Image (1183); Failure to Power Up (1476); Noise, Audible (3273)

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

Event Date 09/06/2023

Event Type  malfunction  

Event Description

During shift check, the customer heard a clicking noise upon powering up the autopulse platform (sn (b)(6) ).After the platform powered up, the lcd screen was blank.No patient involvement.

Manufacturer Narrative

The reported complaints that "a clicking noise was heard upon powering up the autopulse platform (sn (b)(6) ), and the lcd screen was blank" were confirmed during a visual and functional inspection.The lcd screen was observed blank due to the malfunctioning lcd transmissive board.This was caused by a failed processor board, which prevented the platform from powering up.The processor board (pca) failure was likely attributed to the age of the device.The autopulse platform was manufactured in july 2013 and is over 10 years old, well beyond its expected service life of 5 years.The platform was further examined, and it was noted that the power distribution board revision level was below 6 and needed to be updated, attributed to the age of the platform.This observation is unrelated to the reported complaints.An archive review could not be performed because the data could not be downloaded due to the failed processor board.The initial functional test couldn't be performed due to the blank white screen and continuous clicking noise at power up, confirming the reported complaints.The malfunctioning lcd transmissive and processor boards must be replaced to resolve the issues.The customer declined the service repair.This platform remained unrepaired and was labeled with "not for clinical use".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 serial number (b)(6).

• 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: 17846354
• MDR Text Key: 324623971
• Report Number: 3010617000-2023-00824
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/29/2023

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2023
• Initial Date FDA Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/16/2013
• 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