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 Consequences Or Impact To Patient (2199)

Event Date 08/02/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(4)) displaying 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.There were no device deficiencies found during the evaluation of the returned platform that could have caused or contributed to the reported complaint.The autopulse platform worked as intended.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.During visual inspection, there was no physical damage observed on the autopulse platform.The autopulse platform, passed initial functional testing without and faults or errors.During archive data review, ua 45 error messages was observed on the reported event date.The encoder drive shaft is not within the normally acceptable range at 6090 cts when powered on based on (encoder lower_limit = 2735 counts, encoder upper_limit = 3409 counts).In addition, ua 7 (discrepancy between load 1 and load 2 too large) error messages was observed on the reported event date.This is not related to the reported complaint.The load sensing system has detected a weight/load imbalance between the two load cells (checked during power-on-self-test).Load cell characterization test indicated both cell modules are functioning within the specification.The error message might be caused due to the patient not oriented on the autopulse platform correctly or the patient has shifted during compression or take-up.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.Ua 7 error message alerts the operator that the patient is out of position and not properly centered in the platform.This user advisory will persist until the patient is properly aligned.Per the autopulse user guide instruction, to clear the error message, the operator needs to pull up the lifeband until the chest bands are fully extended.Ensuring that the patient and the lifeband are aligned and then restarting the platform.After service, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.

Event Description

During patient use, the autopulse platform (sn (b)(4)) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error message upon power on.The crew attempted to troubleshoot three time but was unsuccessful.The crew immediately performed manual cpr.No consequences or impact to patient.

• 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: 10463762
• MDR Text Key: 205013029
• Report Number: 3010617000-2020-00823
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2020
• 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: 08/10/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2019
• 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