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 Consequences Or Impact To Patient (2199)

Event Date 04/16/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (serial # (b)(4)) did not power on with multiple autopulse li-ion batteries was confirmed based on the archive data review, but not during the functional testing.The autopulse platform worked as intended during the testing.The archive data review showed that the autopulse platform got powered on/off approximately 445 times on the reported event date.Thus, confirming the reported complaint but the cause was undetermined since the platform powered on as intended during the testing.The reported complaint of moisture was observed inside the display screen was not confirmed uring the visual inspection.However, a distorted lcd display was observed.The lcd issue could be related to the moisture inside the display that was reported and may have dried up.The lcd display was replaced to remedy the distorted lcd.Unrelated to the reported complaint, a broken front enclosure was observed on the returned autopulse platform during visual inspection.This type of physical damage on the platform was likely attributed to mishandling such as a drop.The autopulse platform was manufactured in july 2015 and is nearing it expected serviceable life of 5 years.The front enclosure will be replaced to address the damage issue.Initial functional testing on the ap platform passed without any fault or error.Awaiting customer's service repair approval.Historical complaints were reviewed for service information related to the reported complaint and there were no similar complaints reported for autopulse with serial number (b)(4).

Event Description

Customer reported that the autopulse platform (serial # (b)(4)) did not power on with multiple autopulse li-ion batteries.Also, moisture is observed inside the display screen.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: 10043878
• MDR Text Key: 192473394
• Report Number: 3010617000-2020-00462
• 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: 05/11/2020

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: 04/22/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/16/2020
• Initial Date FDA Received: 05/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/13/2015
• 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