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 Consequences Or Impact To Patient (2199)

Event Date 05/28/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse platform ((b)(4)) stopped compressions and displayed "realign patient" message" was confirmed based on the archive data review, but not during the functional testing.The reported complaint was unable to be duplicated during the functional testing.Based on the archive, the cause for the reported complaint was due to user advisory (ua) 02 (compression tracking error) and ua 18 (max take-up revolutions exceeded) error messages.The possible root cause for ua02 error message could be due to the patient misaligned on the platform or the life band is opened or in the incorrect position during take up/compression.The possible root cause for the ua18 error message could be due to the patient is too small or not present or the lifeband is open.Upon visual inspection, no physical damage was observed.The autopulse platform passed the initial functional testing without any fault or error.The archive data review showed that the autopulse platform performed one session of 20 compressions with no weight on the platform and stopped compressions with multiple ua18 error messages and the error messages were cleared.Then, the autopulse platform performed one session of 16 compressions with max load sum of 121 lbs.And stopped due to ua02 error message and was cleared after restarting the platform.Upon restarting, the autopulse platform displayed ua18 error message again.User advisory is a clearable error message, ua02 is an indication that the autopulse has detected a change in lifeband tension.This advisory can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation.The recommended actions to take for this type of user advisory are: ensure that the lifeband is properly closed.Pull up completely on the lifeband, ensure that both 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.In this case, revert to manual cpr.Upon further testing, unrelated to the reported complaint, the autopulse platform failed brake gap inspection and the brake gap was unable to be adjusted within the specification due to defective drive train, likely attributed to normal wear and tear of the device.The autopulse platform was manufactured in 2015 and is more than 5 years old, past the expected service life of 5 years.The drive train needs to be replaced to address the observed problem.Waiting for customer approval for repair.

Event Description

The autopulse platform ((b)(4)) stopped compressions and displayed "realign patient" message on the user control panel.No further information was provided.Patient use information was requested but no additional information was provided, therefore patient use is unknown.

• 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: 10188887
• MDR Text Key: 196294523
• Report Number: 3010617000-2020-00625
• 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: 06/24/2020

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/04/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/29/2020
• Initial Date FDA Received: 06/24/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/27/2015
• 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