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 05/31/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of a user advisory - ua41 (patient temperature sensor failure) error message displayed on the autopulse platform (sn (b)(4)) user control panel was not confirmed during functional testing but confirmed during archive data review.The device functions as intended.The root cause was due to user error because the platform was tested on an airway chair vertically and on the ambulance bench which was a soft surface that may have blocked the air vents which increased the internal temperature of the autopulse platform and cause the occurrence of ua41 error message.During visual inspection, no issue was observed.During archive data review, ua41 was observed.During initial functional testing, no issues were observed.However, during the load cell characterization check it identified a defective load cell.This observation is not related to the reported complaint.Root cause of the damage load cell was due to wear and tear.The autopulse platform is manufactured in 09 may 2014 and is 6 years old.After replacing the temperature sensor as precautionary measure to address ua 41 and replacing the load cell , 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 the functional tests and it is ready for clinical use.

Event Description

During shift check, the autopulse platform (sn (b)(4)) displayed user advisory (ua) 41 (patient temperature sensor failure) error message upon powering on.The error message was initially cleared by the user after replacing the li-ion battery and by re-starting the platform.Later, when the autopulse platform was powered on, the platform displayed ua 41 error message again and the user was unable to clear the ua 41 error message.The user placed the autopulse platform on the airway chair vertically in the ambulance during the ua 41 error message.Following this, the platform was placed on the ambulance bench (soft cushion) and was not able 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: 10197720
• MDR Text Key: 197120652
• Report Number: 3010617000-2020-00627
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/09/2014
• 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