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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 11/16/2021

Event Type  malfunction  

Manufacturer Narrative

The reported complaint that the autopulse platform (serial (b)(4)) displayed user advisory - "(ua)07" (discrepancy between load 1 and load 2 too large) error message upon powering on was confirmed during functional testing and based on the review of the archive data.The root cause of the ua07 advisory message was due to defective load cells, likely attributed to wear and tear.The autopulse platform was manufactured (b)(4) 2009 and is over 12 years old, well past beyond its expected service life of 5 years.Visual inspection of the returned autopulse platform was performed, and no physical damage was observed.Review of the archive data showed multiple user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) on the customer's reported event date; thus, confirming the reported complaint.Functional testing failed due to the ua07 advisory message displayed upon powering up the platform; thus, confirming the reported complaint.Load cell characterization test results confirmed that both load cells were defective.To remedy ua07, the load cells needs to be replaced.Zoll is awaiting on customer's approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for autopulse platform with serial number (b)(4).

Event Description

During patient use, customer reported that the autopulse platform (serial# (b)(4)) displayed user advisory - "(ua)07" (discrepancy between load 1 and load 2 too large) error message upon powering on.The customer was unable to clear the advisory and immediately performed manual cpr.No consequences or impact to the patient.

• 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: 13122526
• MDR Text Key: 283782857
• Report Number: 3010617000-2021-01266
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001076
• UDI-Public: 00849111001076
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 12/30/2021

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: 8700-0740-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/07/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2021
• Initial Date FDA Received: 12/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/15/2009
• 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