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 Insufficient Information (4580)

Event Date 12/07/2021

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the platform however, the investigation is still in progress.A follow-up report will be submitted when the investigation has been completed.

Event Description

As reported, the autopulse platform (serial #(b)(4)) displayed a user advisory - "(ua) 07" (discrepancy between load 1 and load 2 too large) error message.It is unknown where the problem occurred.However, patient use information was requested, but no additional information was provided.

Manufacturer Narrative

The reported complaint that "the autopulse platform (s/n (b)(6) displayed user advisory (ua)07 (discrepancy between load 1 and load 2 too large) upon powering up" was confirmed during functional testing and based on the review of the archive data.The root cause of the ua07 was the defective load cell module 2, likely attributed to mishandling such as a drop or a defective component.Upon visual inspection, no physical damage was observed.A review of the archive data was performed and showed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) around the customer's reported event date; thus, confirming the reported complaint.Also, unrelated to the reported complaint.In addition, unrelated to the reported complaint, the archive data indicated ua12 (lifeband not present) error message around the reported event date.The observed error message was cleared based on the archive and was not reproduced during functional testing.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.Per the battery hangtag - advisory codes description and action, user advisory 12 is an indication that the autopulse has detected that the lifeband is not properly installed.The recommended actions to take for this type of user advisory are: ensure that the band clip (underneath the device) is properly seated in the drive shaft can freely rotate after insertion.Functional testing failed due to the ua07 advisory message displayed upon powering up the platform; thus, confirming the reported complaint.Load cell characterization results confirmed load cell module 2 was defective, and it was replaced to remedy the fault.Following service, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse platform with serial number (b)(6).

• 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 thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 13122525
• MDR Text Key: 283174979
• Report Number: 3010617000-2021-01224
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/21/2022

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: 12/22/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2021
• Initial Date FDA Received: 12/30/2021
• Supplement Dates Manufacturer Received: 01/11/2022
• Supplement Dates FDA Received: 01/21/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2019
• 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