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

Model Number MODEL 100

Device Problems Display or Visual Feedback Problem (1184); Use of Device Problem (1670)

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

Event Date 12/30/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported complaint for the autopulse platform (sn (b)(4)) stopped compressions was not confirmed during archive review and initial functional testing.There were no device deficiencies found during the evaluation.No device malfunction was observed, and it performed as intended.In addition, the reported complaint of various pixel errors on the lcd was not observed during functional testing.Display is functioning properly.Per user request, the lcd will be replaced.Upon visual inspection, unrelated to the reported complaint, observed the encoder drive shaft does not rotate smoothly, exhibits binding and resistance due to a sticky clutch plate.The sticky clutch plate will be deburred to address the issue.The cause for the sticky clutch could be due to normal wear and tear.The impact of a sticky clutch was not severe enough to make the platform non-functional.The autopulse platform is a reusable device and was manufactured in december 2011, and is more than 9 years old, well beyond the expected service life of 5 years.The autopulse passed the initial functional test without any fault or error and no significant discrepancies were found during archive data review.Waiting on customer's approval for the service repair.

Event Description

During patient use, the lifeband (lot # unknown) was unable to retract completely (retracted around 5 to 7 cm) and the autopulse platform stopped compressions.Patient achieved rosc.During testing with manikin, the lifeband was installed and autopulse platform did not start compression when the start button was pressed.Autopulse platform did not display any error message but the display has various pixel errors.No consequences or impact to patient.Please see the following related mfr report: mfr 3010617000-2021-00195 for the lifeband.

• 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: 11355894
• MDR Text Key: 233060190
• Report Number: 3010617000-2021-00114
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• 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: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/29/2011
• 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