MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2019

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (serial #(b)(4)) display of "realigned patient" and then it power off on its own were not confirmed during the initial functional test.The autopulse platform powered on but displayed user advisory - ua16 (timeout moving to take-up position), unrelated to the reported complaint.Unrelated to the reported complaint, a damaged front enclosure on the returned autopulse platform was observed during visual inspection.This type of physical damaged is likely attributed to mishandling.The front cover was replaced.Also found, the encoder drive shaft does not rotate smoothly, exhibits binding and resistance as a result of a sticky clutch plate.Deburring of the sticky clutch plate was performed to remedy the encoder drive shaft issue.The initial functional test failed due to user advisory - ua16 (timeout moving to take-up position).The root cause of ua16 was due to a damaged drive train.The drive train assembly was replaced to addressed the error message.After service 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.The autopulse platform passed all the functional tests and it is ready for clinical use.

Event Description

During patient use, customer reported that the autopulse platform (serial #(b)(4)) powered off on its own after it displayed "realigned patient".Unable to re-power on the platform, crew performed manual cpr.No known impact or consequence to patient was provided.

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 9332343
• MDR Text Key: 167207258
• Report Number: 3010617000-2019-01021
• 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: 11/15/2019

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: 10/30/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/24/2019
• Initial Date FDA Received: 11/15/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/08/2019
• 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
• Patient Age: 50 YR