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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Patient Involvement (2645)

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

The returned autopulse platform (sn: (b)(4)) was serviced for preventative maintenance (pm) on june 8, 2020.During the functional testing, the autopulse platform displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message upon powering up.The root cause for the observed ua07 was due to a defective load cell module 1, which was found over-reported during the load cell characterization test.The broken front enclosure and defective load cell were likely attributed to mishandling such as a drop.The load cell module 1 will be replaced to remedy the fault.Upon visual inspection, the front enclosure was observed worn out and slightly scratched, and there was a vertical crack running through one of the screw fittings.The observed physical damages could be due to normal wear and tear and/or due to user mishandling.The autopulse platform is a reusable device and was manufactured in february 2011, and it is over 9 years old, well beyond its expected service life of 5 years.The damaged front enclosure will be replaced to address the observed issues.Awaiting customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse with serial number (b)(4).

Event Description

The autopulse platform (sn: (b)(4)) was returned for preventive maintenance (pm).During the functional testing, the autopulse platform displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message.

• 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: 10151220
• MDR Text Key: 195166186
• Report Number: 3010617000-2020-00642
• 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: 06/12/2020

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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/08/2020
• Initial Date FDA Received: 06/12/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2011
• 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