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 Consequences Or Impact To Patient (2199)

Event Date 07/31/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn: (b)(4)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message" was confirmed during the functional testing and based on the archive data review.The root cause of the reported complaint was a defective load cell module.The broken top cover and defective load cell module were likely attributed to mishandling such as a drop.During visual inspection of the returned platform, the interior of the top cover was observed to be dirty and dusty.Also, the top cover was noted to be cracked and chipped at multiple locations.In addition, multiple breakages were observed on the screw fittings of the front cover as well as both the front and bottom enclosures.Moreover, the front and bottom enclosures were noted to be worn and scratched.The observed physical damages were unrelated to the reported complaint.The breakages and chipped pieces were appeared to be the characteristics of harsh impact as a result of user mishandling.Observed small scratches and worn-out parts were likely attributed to normal wear and tear.The autopulse platform is a reusable device and was manufactured in march 2007, and it is over 13 years old, has exceeded its expected service life of 5 years.All the damaged parts will be replaced to address the observed issues.The archive data revealed that the autopulse platform was not used to compress either a patient or an object on the reported event date.Review of the archive data showed multiple user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error messages to have occurred on the customer's reported event date; thus, confirming the reported complaint.Unable to perform functional testing due to the ua07 error message displayed upon powering up the platform.Thus, confirming the reported complaint.During power-on-self-test, the single point load cell, connected to amplifier board connector j3, was found to be defective.The defective load cell module will be replaced to remedy the fault.Awaiting the 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

During patient use, the autopulse platform (sn: (b)(4)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message.The user switched to manual cpr, and a second autopulse platform was used to finish the call.No further information was provided by the customer.Patient's status information was requested, but the customer did not provide a response.Therefore, patient's status is unknown.

• 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: 10463860
• MDR Text Key: 206578887
• Report Number: 3010617000-2020-00828
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: 08/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/28/2020
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2007
• 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