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

Model Number MODEL 100

Device Problems Display Difficult to Read (1181); Display or Visual Feedback Problem (1184)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/12/2021

Event Type  malfunction  

Manufacturer Narrative

During the investigation of the returned autopulse platform ((b)(4)), zoll service personnel noticed missing pixels on the bottom half of the lcd screen upon powering on, and the display was unreadable.The lcd was replaced to address the observed issue.The probable root cause for the observed lcd issue could be normal wear and tear or due to mishandling such as drop, as indicated by the broken covers noticed during the visual inspection.The autopulse platform was manufactured in 2011 and is more than ten years old, past the expected service life of 5 years.Upon visual inspection, noticed damage on the top cover, front enclosure, and bent battery lock clip of the autopulse platform.Based on the photo provided by the service team, noticed a crack below the lcd screen on the top cover, a crack on the front enclosure, and a bent battery lock.The observed physical damages appear to be mishandling characteristics, such as a drop.The damaged covers and the battery lock were replaced to address the observed physical damages.The autopulse platform passed the initial functional testing.Also, the autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries for 10 minutes without any fault or error.During service, noticed a crack on the battery compartment, likely caused by mishandling.The battery compartment was replaced to address the observed physical damage.The autopulse platform passed the run-in test and the final testing without any fault or error following the service.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for autopulse platform with (b)(4).

Event Description

During the investigation on 02/12/2021, upon powering on the autopulse platform (sn (b)(4)), zoll service personnel noticed missing pixels on the bottom half of the lcd screen, and the display was unreadable.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 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: 11449136
• MDR Text Key: 244639506
• Report Number: 3010617000-2021-00176
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000277
• UDI-Public: 00849111000277
• 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: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• 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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2011
• 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