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

Model Number MODEL 100

Device Problem Display Difficult to Read (1181)

Patient Problem No Patient Involvement (2645)

Event Date 03/10/2019

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of flickering lcd control panel autopulse platform system (serial # (b)(4)) was confirmed during visual inspection.The most probable root cause was due to the damage processor pca assembly.During visual inspection, the lcd control panel backlight was not functioning due to a damage processor board.Unrelated to the customer reported issue, the autopulse platform front enclosure was found to be cracked.The likely root cause of the observed physical damage was due to user handling.During functional test, the autopulse platform system passed functional testing.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

It was reported that during shift check the user noticed that the autopulse platform resuscitation system liquid crystal display (lcd) control panel was flickering.After replacing the autopulse battery the flickering stopped briefly, but it resumed.It only affects the illumination, not the medical data shown.It was difficult to read the messages on the lcd control panel.No patient involved.

• 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 nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 8489513
• MDR Text Key: 141204648
• Report Number: 3010617000-2019-00261
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/05/2019

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: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/13/2019
• Initial Date FDA Received: 04/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2016
• 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
• Patient Outcome(s): Required Intervention