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 02/26/2021

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(4)) will not display information after power on was confirmed during functional testing and visual inspection.The root cause was a damaged lcd due to a fluid ingress caused by 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." the autopulse platform failed the initial functional test due to a damaged lcd, thus confirming the customer complaint.After lcd screen replacement, the platform was powered on and failed the initial functional test due to the fault code 34 (encoder failure), unrelated to the reported complaint.The fluid ingress, caused by user mishandling, shorted the encoder electronic circuitry.The damaged encoder needs to be replaced to address the fault.Upon visual inspection, unrelated to the reported complaint noticed a cracked front enclosure at the front end area and the bottom enclosure has multiple cracks at the screw well area with missing screws, and, also, a bent battery lock.The observed damages appeared to be the characteristics of user mishandling such as a drop.The bottom and front enclosures and the battery lock need to be replaced to remedy the observed issue.In addition, noticed one of the head restraint was cut/broke off.The cut head restraint does not render the autopulse platform non-functional.The patient head restraint wire could have been cut to free the patient from the platform, or the user could have been lifting the platform by holding the head restraints, likely attributed to user mishandling.The top cover needs to be replaced to address the damage.Also, unrelated to the reported complaint, noted the fluid ingress contamination throughout the interior of the platform, likely attributed to user mishandling.The interior of the autopulse platform is required to have a bio-cleaning.Waiting for customer approval for repair.Historical complaints were reviewed for service information related to the reported complaint (b)(4).

Event Description

During the shift check, the user observed that the lcd screen on the autopulse platform (sn (b)(4)) will not display information after power on.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: 11559185
• MDR Text Key: 244508671
• Report Number: 3010617000-2021-00245
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000772
• UDI-Public: 00849111000772
• 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: 03/23/2021

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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/26/2021
• Initial Date FDA Received: 03/24/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/10/2011
• 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