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 10/29/2020

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform (sn: (b)(4)) for investigation.A follow-up report will be submitted when the product is returned, and the investigation has been completed.

Event Description

During shift check, the autopulse platform (sn: (b)(4)) showed a pixelated lcd black screen, and made a ticking sound upon powering up.No patient involvement.

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(6)) showed a pixilated lcd black screen and made a ticking sound upon powering up was confirmed during functional testing and visual inspection.The root cause was due to a damaged lcd transmissive module and processor board due to fluid ingress likely due to user mishandling.Per autopulse user guide, 4.2.Cleaning the autopulse platform section: "wipe all the surfaces of the autopulse platform free of foreign matter and spills with a disinfectant or bactericidal wipe.Check the vents to ensure that they are free and clear of any obstructive matter.Caution: do not submerge the autopulse in liquid.Ensure that the autopulse is dry before storing." during initial functional testing, the platform failed power on self test and observed with pixilated lcd black screen.During visual inspection, no physical damaged observed.However, after removing the top and the bottom covers of the platform, noticed fluid/blood ingress inside the platform.The interior of the autopulse required to have a bio-cleaning.Top cover needs to be replaced due to corrosion on the metalized surface of the top cover.In addition, observed the encoder drive shaft does not rotate smoothly, exhibits binding and resistance due to a sticky clutch plate, this observation is unrelated to the reported complaint.The probable cause for the sticky clutch could be due to corrosion in the drive train clutch area.The archive data could not be downloaded due to the defective processor board.Waiting for customer's approval for service.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with sn (b)(6).

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 10905703
• MDR Text Key: 219570752
• Report Number: 3010617000-2020-01179
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• 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: 11/20/2020
• Date Manufacturer Received: 11/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1