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 Patient Involvement (2645)

Event Date 08/10/2020

Event Type  malfunction  

Manufacturer Narrative

The primary reported complaint of the autopulse platform (sn (b)(4)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message was confirmed during the initial functional testing and archive data review.The root cause for ua 07 was due to damaged load cells.The damaged load cells were likely due to mishandling such as drop.The secondary reported complaint of the platform displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error message was not confirmed during functional testing; however, was confirmed during archive data review.The root cause for the ua45 error message was due to the driveshaft not being at home position which is likely attributed to user error.Note that the user advisory error messages are designed into the platform when one of several conditions is detected.The error message observed in the archive are easily clearable by user.For example, ua 45 alerts the operator that the autopulse driveshaft is not at its home position when the platform was powered on.This user advisory will persist until the driveshaft is returned to its home position.Per the autopulse user guide instruct, to clear ua 45, the operator needs to pull up the lifeband until the chest bands are full extended.This action will move the driveshaft to its home position.Upon visual inspection, no physical damage was observed.The archive data review showed multiple occurrences of ua07 error message and a single occurrence of ua45.The initial functional testing of the autopulse platform could not be performed due to ua 07 error message displayed upon powering on.The load cell characterization test results confirmed load cells were over reported.The load cells need to be replaced to address the ua07 error.After replacing load cells, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test battery until discharged without any fault or error.The load cell characterization test passed.The autopulse platform passed final test.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint reported for autopulse with serial number 33933.Ccr 50355 reported on 08 july 2020, load cell 2 was replaced.

Event Description

During shift check, the autopulse platform (sn (b)(4)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) and ua 45 (driveshaft not at "home" position after power-on/restart) error messages.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
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, ca ; 4192922
• MDR Report Key: 10492112
• MDR Text Key: 209359735
• Report Number: 3010617000-2020-00854
• 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: 09/03/2020

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: 08/19/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/28/2017
• 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