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

Model Number MODEL 100

Device Problems Failure to Power Up (1476); Power Problem (3010)

Patient Problem No Patient Involvement (2645)

Event Date 04/26/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (serial # (b)(4)) does not power on after it was soft bristle brushed with water and disinfected solutions was not confirmed during initial functional testing.The probable root cause for the reported complaint could be due to temporary presence of moisture in the platform caused by the user's decontamination process.Unrelated to the reported complaint, a cracked front enclosure was observed on the returned autopulse platform during visual inspection.This type of physical damaged cover is likely attributed to mishandling.The damaged front enclosure was replaced.Archive data indicated last power up was on 04/24/2020 with ua02 (compression tracking error).The ua02 error message was cleared by the customer and the platform performed 6 sessions of (111, 14, 232, 209, 294 and 114) compressions on a patient without any fault or error.The initial functional test on the returned autopulse platform failed due to "ua07" (discrepancy between load 1 and load 2 too large) error message upon powering on, unrelated to the reported complaint.The root cause for ua7 was due to a defective load cell.The cracked cover and defective load cell were likely attributed to mishandling such as a drop.The load cell module 1 was replaced to address the load cell issue.After service repair completion, the returned autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test battery until discharged without any fault or error.Load cell characterization check passed.The autopulse platform passed all the functional tests.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number (b)(4).

Event Description

After patient use, customer decontaminated the autopulse platform (serial # (b)(4)) using soft bristle brushed with water and disinfectant solutions.After autopulse platform was dried off, it does not power on with several good fully charged autopulse li-ion batteries.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
• 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: 10081185
• MDR Text Key: 191858794
• Report Number: 3010617000-2020-00517
• 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: 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/21/2020
• 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: 05/06/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/27/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2016
• 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