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	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
During training with the autopulse platform (sn (b)(6), after powering on and sizing the mannequin, the platform performed a few compressions.It stopped, displaying "pull up lifeband, check patient alignments, and press restart." the crew tried readjusting and repositioning the lifeband and the mannequin multiple times, but the issue continued.The video provided by the customer showed that the autopulse platform displayed a user advisory 19 (max applied load exceeded) message.No patient involvement.
Additional Manufacturer Narrative
Zoll has not received the autopulse platform for investigation.A follow-up report will be submitted if and when the product is returned, and the investigation has been completed.
Additional Manufacturer Narrative
The customer's complaint that the autopulse platform (sn: (b)(6) displayed a user advisory 19 (max applied load exceeded) message and prompted "pull up lifeband, check patient alignments, and press restart" was confirmed based on the archive data review but was not reproduced during the functional testing.No device malfunctions were observed during testing, and the platform functioned as intended.The archive data indicated the occurrence of ua19, confirming the complaint.Based on the archive review, there were multiple incidents in which the device stopped compressing due to ua 19.The max load sum indicated loads ranging from 357 to 392 lbs.Were applied during the incident.The likely root cause of the reported ua19 was the load plate detecting too much weight (>270 lbs./123kg) due to the patient's chest size and stiffness, or because the patient shifted during compression.The autopulse platform passed functional testing without any faults or errors.The brake gap inspection was performed, and the brake gap was verified to be within specification.A load cell characterization test was performed, confirming that both cell modules function within specification.The platform was tested using the lrtf until the battery was completely discharged, with no faults or errors detected.The autopulse platform functioned appropriately and performed as intended.Following service, the autopulse platform passed the run-in and final tests without fault or error.

• 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: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 23744908
• Report Number: 3010617000-2025-00895
• Device Sequence Number: 8469574
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/11/2026

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: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2025
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 03/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/22/2022
• 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