MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Power Problem (3010)

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

Event Date 05/13/2021

Event Type  malfunction  

Manufacturer Narrative

During device evaluation and functional testing performed at zoll, the autopulse platform (s/n (b)(4)) failed the initialization (power-on-self-test).The root cause of the issue was the defective processor board, likely due to the aging of the device.The autopulse platform was manufactured in september 2010, and it is almost 11 years old, well beyond its expected service life of 5 years.However, user mishandling/neglect cannot be ruled out as no documented report was found showing that regular preventative maintenance (pm) was performed since the device was acquired by the customer.Performing regular preventive maintenance would help identify and prevent system failure during clinical deployment.The defective processor board was replaced to remedy the fault.Visual inspection of the autopulse platform was performed.It was noted that the front and bottom enclosures had multiple cracks in their screw well areas.The observed physical damages appeared to be the characteristics of harsh impact due to user mishandling.The damaged enclosures will be replaced to address the issues.After removing the front and the bottom covers of the platform, massive fluid and/or blood ingress was found inside the autopulse platform, attributed to user mishandling.The contamination had formed corrosion on the top cover metalized inner surface.The top cover will be replaced, and the interior of the autopulse platform will be bio-cleaned to address the issue.Awaiting the customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for autopulse platform with serial number (b)(4).

Event Description

During device evaluation and functional testing of the autopulse platform (s/n (b)(4)), the platform failed the initialization (power-on-self-test).No patient involvement.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• 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: 11943700
• MDR Text Key: 254528569
• Report Number: 3010617000-2021-00484
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2021
• 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: 05/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/30/2010
• 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