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

Model Number MODEL 100

Device Problems Loss of Power (1475); Visual Prompts will not Clear (2281)

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

Event Date 01/30/2023

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned, and investigation has been completed.

Event Description

During training with a manikin, the autopulse platform (sn 36474) displayed fault code 16 (timeout moving to take-up position) and ua23 (compression will exceed 3 revolutions) error messages, and shut down by itself.No patient involvement.

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn (b)(6) displayed "fault code 16" (timeout moving to take-up position) and user advisory "(ua) 23" (compression will exceed 3 revolutions) error messages" were confirmed during archive data review but not during the functional testing.Based on the archive, the autopulse did not achieve the target depth for take-up within the specified time (~5 secs) due to the drive train motor having rust/corrosion at the brake assembly area.The brake body was seized from the rust/corrosion, which prevented the brake from opening/closing during activation.This caused fault 16 and ua23 errors and prevented the platform from performing compressions.Frequent daily device checks and storing the autopulse platform in a low humidity location could help prevent the brake gap from seizing.Also, no documented report was found showing that regular preventative maintenance (pm) was performed on the autopulse platform since it was acquired by the customer in 2016.The lack of regular maintenance could lead to degradation of the mechanical components of the drive train, including brake seizure.The other reported complaint that the "the autopulse platform shut down by itself" was not confirmed during functional testing.The autopulse platform passed the functional test without any fault or error and did not shut down by itself.During visual inspection, no physical damage on the autopulse platform was observed.Based on archive data review, multiple fault code 16 (timeout moving to take-up position) and ua23 (compression will exceed 3 revolutions) error messages were observed on the event date, thus, confirming the reported complaint.Also, unrelated to the reported complaint, the archive also revealed occurrences of multiple fault code 28 (loss of clutch connectivity) and fault code 29 (loss of brake connectivity).The brake and clutch monitoring circuit detected a loss of connectivity on the brake and clutch driving circuit during active operation.As a precautionary measure, the power distribution board (pdb) will be replaced to address the fault code 28 and fault code 29 observed in the archive.The autopulse platform passed the preliminary functional test without any fault or error.However, observed the drive train motor appears to have rust/corrosion at the brake housing.The motor's brake assembly was seized and prevent the motor from rotating (initiate compression) which likely generated the intermittent fault code 16 and ua 23 errors observed in the archive data.To remedy the fault code 16 and ua 23, ipa was used to clean and remove rust/corrosion at the brake housing area.The brake gap inspection was performed and verified the brake gap was within the specification of 0.008" ±0.001".The platform was tested with the large resuscitation test fixture (lrtf) without any fault or error.Zoll is awaiting customer approval for service repair.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints for 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 thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 16469114
• MDR Text Key: 310527611
• Report Number: 3010617000-2023-00190
• 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: 04/28/2023

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2023
• Initial Date FDA Received: 03/02/2023
• Supplement Dates Manufacturer Received: 04/03/2023
• Supplement Dates FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/02/2021
• 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