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 08/04/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (serial #(b)(4)) displayed fault code 16 (timeout moving to take-up position) error message was confirmed during the initial functional testing and archive data review.The root cause for the reported complaint was due to the drive train motor had rusted/corroded at the brake housing area, causing the brake assembly to seized.This type of corrosive damage is indicative of either non-usage of the autopulse platform for infrequent daily checks.In the warm and humid climate, the drive train motor brake will seize if the platform is not powered on frequently.Per archive, the autopulse was not powered on for more than a month.During visual inspection, cracked front enclosure at the front end area was observed on the autopulse platform, unrelated to the reported complaint.The root cause for the observed physical damage could be due to mishandling such as drop.The front enclosure was replaced to address this issue.During archive data review, multiple fault code 16 were recorded, thus, confirming the reported complaint.The autopulse platform failed initial functional testing due to fault code 16 error message displayed during take-up; thus, confirming the reported complaint.The investigation findings revealed the autopulse platform had no brake activation.It was noticed that the drive train motor had rusted/corroded at the brake housing area and caused the brake assembly to seize.To remedy this issue, the corrosion at the brake assembly was removed using ipa (isopropyl alcohol).After removing the corrosion, the autopulse platform was connected to a power supply and applied 12v to the brake cable of the drivetrain motor to activate the brake (un-seized).The brake gap inspection was performed and verified the brake gap was within the specification.Following service, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The return autopulse platform passed all functional testing.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint for autopulse with serial number (b)(4).Ccr (b)(4), reported on 12/09/2019.Autopulse displayed fault code 16 and the root cause was due to seized brake assembly.

Event Description

During patient use, customer reported that the autopulse platform (serial #(b)(4)) displayed fault code 16 (timeout moving to take-up position) error message.Crew was unable to clear error message and immediately performed manual cpr.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: 10457532
• MDR Text Key: 204635872
• Report Number: 3010617000-2020-00825
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2020
• 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: 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: 06/08/2017
• 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