MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/25/2024

Event Type  malfunction  

Manufacturer Narrative

During preventative maintenance (pm) performed on (b)(6)2024 the autopulse platform ((b)(6) failed the load cell characterization test.The damaged front enclosure and failed load cell were likely attributed to mishandling such as a drop.The load cell was replaced to remedy the fault.Upon visual inspection, noticed a cracked front enclosure.The probable root cause for the observed physical damage could be due to user mishandling such as a drop.The front enclosure was replaced to address the observed physical damage.As part of routine service during testing, the platform was examined, and the encoder drive shaft does not rotate smoothly and exhibits binding and resistance due to a sticky clutch plate.The sticky clutch plate was deburred to address the issue.The autopulse platform passed the initial functional testing without any fault or error.Upon further testing, the autopulse platform failed the load cell characterization test as load cell module 1 was exceeding normal parameters.The failed load cell module 1 was replaced to address the observed failure.The autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries for 15 minutes without any fault or error.Waiting for customer approval for service.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for the autopulse platform with (b)(6).

Event Description

During preventative maintenance (pm) performed on (b)(6)2024, the autopulse platform ((b)(6) failed the load cell characterization test.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• 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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131
• MDR Report Key: 18995885
• MDR Text Key: 338836418
• Report Number: 3010617000-2024-00319
• 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: User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: 03/21/2024
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/18/2021
• 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