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 reported complaint of the autopulse platform (serial #(b)(4)) displayed a user advisory - "(ua)45" (not at "home" position after power-on/restart) error message upon powering on was confirmed during initial functional testing and during archive data review.The root cause for the reported ua45 error message was due to the encoder drive shaft was not at its "home" position likely attributed to user error.Per the autopulse resuscitation system model 100 user guide, if the driveshaft is not at its home position when the autopulse is powered on.A user advisory - (ua) 45 will occur.This user advisory will persist until the driveshaft is returned to its home position.To clear a user advisory - ua45, pull up on the lifeband until the chest bands are fully extended (thereby moving the driveshaft back to its home position), and then restart.During visual inspection, observed a cracked front enclosure on the autopulse platform, unrelated to the reported complaint.The root cause for the observed physical damage was likely a characteristic of mishandling, such as drop.The front enclosure was replaced to address this issue.During archive data review, multiple ua45 errors were recorded, thus confirming the reported complaint.Initial functional testing failed due to ua45 (not at "home" position after power-on/restart) error message displayed during power on.Thus, confirming the reported complaint.To remedy ua45, the driveshaft was rotated back to "home" position by using the administrative menu.After service repair completion, 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 autopulse platform passed all functional tests.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 shift check, customer reported that the autopulse platform (serial #(b)(4)) displayed a user advisory - "(ua) 45" (driveshaft not at "home" position after power-on/restart) error message.Customer was unable to clear error message.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: 10492767
• MDR Text Key: 205720165
• Report Number: 3010617000-2020-00852
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: 09/04/2020

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/10/2020
• Initial Date FDA Received: 09/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2013
• 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