MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. AUTOPULSE®RESUSCITATION SYSTEM; CARDIAC RESUSCITATOR, LINE-POWERED

Model Number	100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	02/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that the autopulse platform (sn (b)(6)) displayed fault code 16 (timeout moving to take-up position) was confirmed in the archive data and during functional testing.The root cause of the reported complaint was a seized brake assembly due to rust and corrosion.Review of the autopulse platform archive revealed that daily checks had not been performed.The platform's storage condition is not known; however, the customer is in florida, which is a high-humidity location.Required daily device checks per the zoll user manual and storing the autopulse in a low-humidity location help prevent the brake from seizing.A review of the archive data showed multiple fault code 16 (timeout moving to take-up position) occurred on the reported event data, confirming the reported complaint.The autopulse platform failed the initial functional test due to fault code 16 observed during take-up, confirming the reported complaint.No brake activation (open/clicking sound) was detected when the platform was powered on.The autopulse did not reach the target take-up depth within the specified timeframe (~5 seconds) due to rust and corrosion present at the drivetrain motor brake assembly.The brake body was seized as a result of the rust/corrosion, preventing the brake from opening or closing during activation.This condition resulted in fault code 16 and prevented the platform from performing compressions.Isopropyl alcohol (ipa) was used to clean and remove the rust and corrosion from the brake housing area.The brake gap was then measured and verified to be within specification at 0.008" ± 0.001".Subsequently, the platform was tested using the large resuscitation test fixture (lrtf) and operated without fault or error.Following service, the autopulse platform passed all testing criteria.Historical complaints were reviewed for service information related to the reported complaint, and there were no similar complaints reported for the autopulse platform with serial number (b)(6).
Event or Problem Description
The autopulse platform (sn (b)(6)) displayed fault code 16 (timeout moving to take-up position).The customer tried a different lifeband, but the fault would not clear.No further information was provided.It is unknown when the problem occurred.However, patient use information was requested, but no additional information was provided.

• Brand Name: AUTOPULSE®RESUSCITATION SYSTEM
• Common Device Name: CARDIAC RESUSCITATOR, LINE-POWERED
• Manufacturer (Section D): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC.; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 24706765
• Report Number: 3010617000-2026-00171
• Device Sequence Number: 16091309
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/26/2026

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
• Operator of Device: Health Professional
• Device Model Number: 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Initial Report FDA Received Date: 03/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown