MAUDE Adverse Event Report: ZOLL CIRCULATION INC 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 01/26/2024

Event Type  malfunction  

Event Description

During device evaluation and functional testing of the auto pulse platform (sn (b)(6) , the platform failed the initialization (power-on-self-test) and the lcd display is blank.No patient involvement.

Manufacturer Narrative

During device evaluation and functional testing of the autopulse platform (sn (b)(6), the platform failed the initialization (power-on-self-test) and the lcd display was blank.The root cause for the observed issues was due to the defective processor pca board, likely attributed to a defective component.During visual inspection, the front and bottom enclosure was observed to be cracked at the screw well area.The observed physical damages appeared to be the characteristics of user mishandling, such as a drop.The front and bottom enclosures were replaced to address the issues.When both front and bottom covers were removed, a lot of fluid ingress was observed to have corroded/damaged the blue case (top cover) metalized coating.The top (blue) cover was replaced and the autopulse was bio-cleaned.The autopulse platform failed the initial functional testing during the power-on-self-test.The device powered on with the lcd displayed blank screen.The repetitive reset clicking sounds were observed and active operation could not be achieved.The processor pca board was replaced to address the observed failure.During servicing, the channel die-cast was observed to be heavily contaminated from fluid ingress and was replaced.Also, both single point load cells were observed to be over-reporting.The failure of the load cells is likely attributed to mishandling, such as a drop.Both load cells were replaced to remedy the issue.Following service, the autopulse platform passed the load cell characterization test and run-in test without any fault or error.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported issue and there was no similar complaints reported for autopulse platform with sn (b)(6).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18736038
• MDR Text Key: 335941185
• Report Number: 3010617000-2024-00157
• Device Sequence Number: 1
• Product Code: DRM
• 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: 02/19/2024

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: 01/25/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2024
• Initial Date FDA Received: 02/19/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/26/2022
• 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