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

Model Number MODEL 100

Device Problems Electrical /Electronic Property Problem (1198); Unexpected Shutdown (4019)

Patient Problem No Patient Involvement (2645)

Event Date 05/26/2019

Event Type  malfunction  

Manufacturer Narrative

The customer reported complaint of "the autopulse platform (sn (b)(4)) powered off on its own after several seconds upon powering on" was not confirmed during the functional testing and the archive data review.The platform passed the functional testing and performed as intended.Since the lifeband was discarded by the customer, physical investigation of the lifeband could not be performed.Upon visual inspection, unrelated to the reported complaint, noticed loose screws, broken head restraint, damaged boss on the top cover and sticky clutch.The physical damage appeared to be caused by mishandling.The autopulse platform passed initial functional testing without any fault or error.The archive data review showed occurrence of user advisory (ua) 07 (discrepancy between load 1 and load 2 too large), ua17 (max motor on time exceeded during active operation), ua18 (max take-up revolutions exceeded) and ua20 (position out of range) error messages around the reported complaint date.User advisory is a clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.Ua07 is an indication that the load sensing system has detected a weight/load imbalance between the two load cells.The recommended actions to take for this type of user advisory are: ensure the patient is properly aligned (armpits on the yellow line), deploy the shoulder restraint to mitigate patient movement and press restart to clear the ua.Ua17 is an indication that the lifeband is twisted or battery voltage is low.The recommended actions to take for this type of user advisory are: open lifeband, start manual cpr, check battery and lifeband, pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.Ua18 is an indication that the autopulse has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform.The recommended actions to take for this type of user advisory are: pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.If the user advisory does not clear, the patient may be too small.Ua20 error message alerts when the drive shaft is not within the specified range of positions.This can be cleared by returning the drive shaft to home position using the administrative menu.Upon service completion, the autopulse platform will be tested to full specification.

Event Description

During shift check, the autopulse platform (sn (b)(4)) powered off on its own after several seconds upon powering on.Per customer, the battery (sn (b)(4)) was successfully charged prior inserting to the platform and the battery status led's showed solid green lights.No device malfunction was reported on the battery.Per distributor, the lifeband looked twisted and the lifeband was disposed by the customer.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 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: 8683232
• MDR Text Key: 148177882
• Report Number: 3010617000-2019-00495
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• 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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2015
• 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