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

Model Number MODEL 100

Device Problem Unexpected Shutdown (4019)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/06/2020

Event Type  malfunction  

Manufacturer Narrative

The customer's reported complaint of the autopulse platform powering off during the patient call was confirmed during the archive data review and during our functional testing at the zoll service center.The root cause of the reported issue was due to a defective drivetrain motor, likely due to a latent manufacturing defect.Upon visual inspection of the autopulse platform, no physical damage was observed.The archive data review showed the occurrence of multiple fault code 28 (loss of clutch connectivity) and fault code 29 (loss of brake connectivity) error messages on the reported event date.These error codes indicate that there was a loss of connectivity to the circuitry for the system clutch and brake, respectively, and would result in the autopulse powering off.The observed fault codes are a characteristic of the failing drivetrain motor assembly.The autopulse platform passed the initial functional testing without any fault or error, however, during the run_in test using the 95% patient test fixture (lrtf), the platform failed with the system error 139 (unable to hold compression position) message, thus confirming defective drivetrain motor.The drivetrain motor brake assembly air gap was too wide, measured at 0.5", out of the specification (0.008" ± 0.001"), which caused the system error 139.The brake gap could not be adjusted in our factory and continued to open out of specification.Also, there was no brake activation upon powering on.The drivetrain motor was replaced to remedy the error.Following the service, the autopulse was subjected to the run-in test using a 95% patient large resuscitation test fixture (lrtf) with the customer's returned batteries (s/n (b)(4)) until fully discharged with an average platform run time of 35 minutes without resulting in any fault or error.No device malfunction was observed during the testing of the returned batteries and the batteries performed as intended.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with serial number (b)(4).

Event Description

During patient use, the customer reported that the autopulse platform (sn (b)(4)) powered off.The user replaced 3 fully charged batteries (sn (b)(4)), however, the issue persists.No additional information was provided.The patient's status information was requested but the customer did not provide a response, therefore patient's status is unknown.Please see the following related mfr reports: mfr 3010617000-2020-00739 for battery sn (b)(4).Mfr 3010617000-2020-00740 for battery sn (b)(4).Mfr 3010617000-2020-00741 for battery sn (b)(4).

• 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: 10353717
• MDR Text Key: 201381380
• Report Number: 3010617000-2020-00738
• 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: 07/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2020
• 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: 07/13/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/21/2019
• 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