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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 02/20/2024

Event Type  malfunction  

Manufacturer Narrative

During device evaluation and servicing of the autopulse platform (sn (b)(6)), the platform failed functional testing due to user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) upon powering up.The root cause of the ua07 was due to failed load cells, likely attributed to failed component(s), or mishandling such as a drop.Both the malfunctioning load cells were replaced to remedy the ua07 advisory message.The customer had sent the platform to zoll for evaluation and servicing because the platform was making a grinding/squealing noise during functional testing performed on a mannequin.This initially reported issue was verified during the visual and functional inspection at zoll.A brake gap inspection was performed and verified the brake gap was within the specification.To further troubleshoot the issue, zoll service personnel used ipa (isopropyl alcohol) to clean the brake housing area while the autopulse platform was running in manufacturing mode.Cleaning the brake gap resolved the reported grinding/squealing noise issue.Subsequently, the autopulse platform successfully passed a run-in test using the large resuscitation test fixture (lrtf) for 15 minutes.Visual inspection of the returned autopulse platform showed no physical damage.Further inspection revealed that the clutch plate was sticky, unrelated to the noted device failure of the ua07 advisory message.The sticky clutch plate is usually caused by sharp edges of the armature plate, or due to burrs on the surface of the clutch rotor.The impact of the sticky clutch was not severe enough to make the platform non-functional.The clutch plate was deburred to remedy the problem.Unrelated to the observed ua07 advisory message, it was also noted that the shaft lock plunger was worn out.The impact of the noted issue was not severe enough to make the platform non-functional.The worn-out shaft lock plunger was replaced to address the issue.Following service, another load cell characterization test was performed and confirmed that both cell modules were functioning within the specification.The autopulse platform was subjected to a final run-in test using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the autopulse platform with serial number (b)(6).

Event Description

During device evaluation of the autopulse platform (b)(6), the platform failed functional testing due to user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) upon powering up.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: kim thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18918794
• MDR Text Key: 337856600
• Report Number: 3010617000-2024-00290
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/15/2024

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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/20/2024
• Initial Date FDA Received: 03/15/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/15/2021
• 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