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 Known Impact Or Consequence To Patient (2692)

Event Date 01/13/2019

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of user advisory - ua07 (discrepancy between load 1 and load 2 too large) on the autopulse platform (serial #(b)(4)) was confirmed during functional testing and archive data review.The investigation findings revealed that the root cause of the reported issue was due to a defective load cell module 1 as a result of an aging component.Unrelated to the reported complaint, a cracked front enclosure on the autopulse platform was observed during visual inspection.This type of physical damage likely attributed to wear and tear.The autopulse platform is a reusable device and was manufactured in october 2011.The device has been operating for over 7 years and has exceeded its expected serviceable life of 5 years.The damaged front enclosure was replaced.During archive data review, multiple ua07 error messages were observed on the event date.Thus, confirming the reported complaint.The initial functional testing of the autopulse platform could not be performed due to ua07 (discrepancy between load 1 and load 2 too large) displayed upon powering on.Thus, confirming the reported complaint.To remedy ua07, the defective load cell module 1 identified during service evaluation was replaced.The autopulse platform was re-tested and passed all functional tests.The autopulse platform is ready for clinical use.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number (b)(4).

Event Description

During device use on a (b)(6) patient in cardiac arrest, customer reported that the autopulse (serial #(b)(4)) displayed user advisory - ua07 (discrepancy between load 1 and load 2 too large) error message upon powering on.Crew immediately performed manual chest compressions.After the incident, the customer tried to clear the ua07 but issue persisted.No known impact or consequence to patient information was available.

• 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 nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 8322778
• MDR Text Key: 136152123
• Report Number: 3010617000-2019-00100
• 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: 02/08/2019

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/17/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/14/2019
• Initial Date FDA Received: 02/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2011
• 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
• Patient Age: 65 YR