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

Model Number MODEL 100

Device Problems Use of Device Problem (1670); Visual Prompts will not Clear (2281)

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

Event Date 12/06/2023

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the product for evaluation, however, the investigation is pending.A follow up report will be filed when the investigation has been completed.

Event Description

During the patient call, the autopulse platform (sn (b)(6) stopped after performing compressions for 2-3 minutes.The crew switched to manual cpr for the rest of the call.No consequences or impact to the patient.After the call, back at the station, the platform was tested and displayed a user advisory (ua) 45 (not at "home" position after power-on/restart).The (ua) 45 error was cleared after the drive shaft was rotated to the home position; however, the platform displayed a (ua) 12 (lifeband not present) error message.The (ua) 12 was cleared after the lifeband was reattached.During the follow-up call with the zoll representative, the platform was powered on and displayed a user advisory (ua) 28 (loss of clutch connectivity) error message.The customer was unable to clear the error.

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(6) stopped after performing compressions for 2-3 minutes was confirmed during the functional testing and the archive data review.Based on the archive review, the autopulse platform stopped compressions after displaying fault code 27 (encoder fault (>3000 rpm)) and fault code 28 (loss of clutch connectivity), followed by the user advisory (ua) 45 (not at "home" position after power-on/restart) error message on the reported event date as a result of a defective encoder which was likely attributed to a defective component.Upon visual inspection, observed a cracked top cover, front and bottom enclosures, and a damaged battery lock, unrelated to the reported complaint.This type of physical damage found during visual inspection is characteristic of the user mishandling such as a drop.The top cover, front, and bottom enclosures with the battery lock were replaced to address the physical damage.As part of routine service during testing, the platform was examined, and unrelated to the reported complaint, 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 archive data review showed the platform stopped compressions multiple times due to fault code 27 and fault code 28.The autopulse platform stopped compression due to the encoder indicating the drive shaft is turning too fast at a speed higher than 3000 rpm during compression due to a defective encoder.Also, a review of the archive found multiple user advisory (ua) 45 error messages as a result of a failing encoder.The platform failed the initial functional test with a user advisory (ua) 45 error message.After the driveshaft was moved to the home position, the platform displayed the fault code 28 message.The encoder gearbox was replaced to address the fault codes and errors observed in the archive.Upon further evaluation, unrelated to the reported complaint, the load cell characterization test failed as the load cell modules were over-reporting.The damaged cover with enclosures observed during the visual inspection and failed load cells were likely attributed to mishandling such as a drop.The load cells were replaced to remedy the fault.In addition, unrelated to the reported complaint, during further functional testing, noticed no brake activation (open/clicking sound) when the platform was powered on.The drive train motor seized up and had corrosion at the brake housing area.The corrosion at the brake housing area was removed using ipa (isopropyl alcohol).A brake gap inspection was then performed and verified the brake gap was within the specification.A review of the autopulse platform archive revealed that frequent daily checks were not performed by the customer.Therefore, this type of corrosive damage is indicative of infrequent daily checks, as a result of user mishandling.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 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 sn (b)(6).

• 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 nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 18407205
• MDR Text Key: 331483817
• Report Number: 3010617000-2023-01091
• 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,Followup
• Report Date: 01/24/2024

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: 12/19/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/27/2023
• Supplement Dates Manufacturer Received: 12/28/2023
• Supplement Dates FDA Received: 01/24/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2021
• 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