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

Model Number	MODEL 100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Insufficient Information (4580)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has received the autopulse platform for investigation.A follow-up report will be submitted when the investigation has been completed.
Event or Problem Description
Resuscitation setting based on emboli.For this, the patient was administered actilyse and then the customer started mechanical chest compressions using autopulse platform (sn (b)(6)).About 15 seconds after actilyse was started, the platform stopped compressions without intervention of a vpk.Due to this issue, the customer switched to manual compressions and restarted the autopulse platform.This occurred for 5 to 6 blocks after each rhythm check.This affected the continuity of compressions (switching between manual and mechanical cpr).Finally, the customer switched to manual compressions and use of the platform was discontinued.The autopulse showed no obvious error message.In both the continuous compression mode and the 30:2 mode, the platform stops after 15 seconds.No additional information was provided.Patient's status information was requested but the customer did not provide a response.
Event or Problem Description
Based on the 4 h's and 4 t's in the als protocol, the site arrived at a possible embolism.For this, the patient was administered actilyse and then, the customer started mechanical chest compressions using autopulse platform (b)(6).About 15 seconds after actilyse was started, the platform stopped compressions without intervention of a nurse.Due to this issue, the customer switched to manual compressions and restarted the autopulse platform.This occurred for 5 to 6 blocks after each rhythm check.This affected the continuity of compressions (switching between manual and mechanical cpr).Finally, the customer switched to manual compressions and use of the platform was discontinued.The autopulse showed no obvious error message.In both the continuous compression mode and the 30:2 mode, the platform stops after 15 seconds.Patient's status information was requested but the customer did not provide a response.
Additional Manufacturer Narrative
B5 (describe event or problem) was updated.With additional information.The reported complaint that the autopulse platform (b)(6) stops compressions was confirmed during the archive data review but not during functional testing.Based on the archive data review, the platform displayed multiple user advisory (ua) 17 (max motor on-time exceeded during active operation) error messages.The root cause was related to the brake gap being outside of specification, so failures can occur under heavy load.Visual inspection of the returned platform was performed, and no physical damage was observed.The brake gap was observed to be out of specification, related to the reported complaint.The brake gap was adjusted to remedy the issue.A review of the archive data showed user advisory (ua) 17 (motor on for too long during active operation), confirming the reported complaint.The autopulse platform passed the initial functional testing without any faults or errors.Following service, the autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) without any fault or error.The autopulse platform passed the final testing 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 for autopulse platform with sn (b)(6).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• 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 ; 4084192922
• MDR Report Key: 19494109
• Report Number: 3010617000-2024-00464
• Device Sequence Number: 15230552
• Product Code: DRM
• UDI-Device Identifier: 00849111001076
• UDI-Public: 00849111001076
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 07/08/2024

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Supplement Date Received by Manufacturer: 06/10/2024
• Initial Report FDA Received Date: 06/08/2024
• Supplement Report FDA Received Date: 07/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2013
• 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