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 08/05/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (serial #(b)(4) displayed "realign patient" error message was not confirmed during functional testing but confirmed during archive data review.The autopulse platform passed the initial functional test without any fault or error.No device malfunction was observed and it performed as intended.The probable root cause of the error message was due to the stiffness of the patient's chest.No physical damage was observed on the autopulse platform during visual inspection but the drive shaft was exhibiting binding and resistance due to a sticky clutch.Deburring of the sticky clutch plate needs to be performed to remedy this issue, unrelated to the reported complaint.During archive data review, multiple user advisory (ua)17 (max motor on time exceeded) error message were recorded around the reported event date, thus confirming the customer's complaint.User advisory is the clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.User advisory ua17 error message alerts the user that the drive motor did not reach the target depth within specification when used on a medium/large size stiff patient.Based on the archive, the drive motor was on for more than 265ms during compression without a low battery warning and autopulse did not reach target depth within the specification due to the stiffness of the patient's chest.Awaiting customer's approval for service repair.

Event Description

During patient use, customer reported that the autopulse platform (serial #(b)(4)displayed "realign patient" error message.Crew was unable to clear the error message.Patient's status information was requested but the customer did not provide a response, therefore patient's status 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: 10463947
• MDR Text Key: 209169774
• Report Number: 3010617000-2020-00833
• 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: 08/27/2020

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: 08/24/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/28/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/21/2017
• 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