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 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (serial #(b)(4)) displayed a user advisory - "(ua) 20" (position out of range) error message upon powering on was confirmed during initial functional testing and during archive data review.The root cause for the reported (ua) 20 error message was due to encoder drive shaft not to be at "home" position, most likely attributed to unintended user error.User advisory is the clearable error message.User advisory (ua) 20 error message was due to the encoder drive shaft not being within the normally acceptable range of positions.Typically, if the user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error message is not resolved properly, it leads to (ua) 20 because the drive shaft is not restored at the home position.Unrelated to the reported complaint, a cracked front and bottom enclosures were observed on the returned autopulse platform during visual inspection.The damaged covers are likely a characteristic of mishandling.The front and bottom enclosures were replaced.During archive data review, multiple errors ua20 were recorded on the reported event date.Thus, confirming the reported complaint.Initial functional testing failed due to ua20 (position out of range) displayed during power on using a known good autopulse li-ion battery.To remedy ua20, the driveshaft was rotated back to "home" position by using the administrative menu.Thus, confirming the reported complaint.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) 20" (position out of range) error message upon powering on.Customer was unable to clear the error.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: 10221583
• MDR Text Key: 197773112
• Report Number: 3010617000-2020-00650
• 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: 07/01/2020

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: 06/16/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2020
• Initial Date FDA Received: 07/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2008
• 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