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

Model Number MODEL 100

Device Problems Display or Visual Feedback Problem (1184); Power Problem (3010)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/26/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (serial # (b)(4)) doesn't completely powers on was not confirmed during the initial functional testing, the returned autopulse does power on as intended, however, the lcd display was flashing/flickering.The investigation findings revealed that the root cause of the reported lcd issue was due to a damaged processor board.The probable root cause could be likely due wear and tear, since the device is 5 years old.The returned autopulse platform was manufactured in march 2015, it has reach its serviceable life of 5 years.Unrelated to the reported complaint, a cracked top cover was observed on the returned autopulse platform during visual inspection.The damaged top cover may have likely attributed to mishandling such as drop.The top cover will be replaced to address the damaged cover issue.Initial functional test on the returned autopulse platform passed, however, the lcd display flickers, thus confirming the reported complaint.The processor board will be replaced to remedy the display issue.Awaiting customer's approval for service repair.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

Customer reported that the autopulse platform (serial # (b)(4)) doesn't completely powers on and the lcd display was flashing/flickering.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: 10081188
• MDR Text Key: 191858211
• Report Number: 3010617000-2020-00579
• 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

• 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: 05/01/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/27/2020
• Initial Date FDA Received: 05/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2015
• 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