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	12/31/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The autopulse platform (sn (b)(6)) in this complaint will not be returned to zoll for evaluation.The customer cleared the user advisory 45 (not at "home" position after power-on/restart) with the instruction sheet received from zoll.User advisory is a clearable message designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the autopulse resuscitation system model 100 user guide, if the driveshaft is not at its home position when the autopulse is powered on, a user advisory (45) will occur.This user advisory will persist until the driveshaft is returned to its home position.To clear a user advisory (45) pull up on the lifeband until the chest bands are fully extended (thereby moving the driveshaft back to its home position), then restart.
Event or Problem Description
The customer reported that the autopulse platform (sn (b)(6)) displayed a user advisory 45 (not at "home" position after power-on/restart) message.The customer cleared the ua by following the instruction sheet emailed by zoll personnel.It is unknown when the problem occurred.However, patient use information was requested, but no additional information was provided.
Additional Manufacturer Narrative
The autopulse platform ((b)(6)) was returned to zoll for evaluation.The reported complaint of the autopulse platform displayed a user advisory 45 (not at "home" position after power-on/restart) message, which was confirmed based on the archive data review but not during the functional testing.The reported ua45 was not reproduced during the testing because the customer cleared the error by following the zoll-provided instruction sheet.Upon further inspection, a sticky clutch was noted due to the worn-out integrated encoder.The integrated encoder was replaced, and the clutch was deburred as a preventive precautionary measure to address the ua45 and sticky clutch.The archive data indicated multiple ua45 errors, confirming the reported complaint.The autopulse platform passed the functional testing with no error or fault.Zoll is awaiting customer approval for service repair.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaint was reported for the autopulse platform with (b)(6).

• 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: 21270136
• Report Number: 3010617000-2025-00063
• Device Sequence Number: 8156899
• Product Code: DRM
• UDI-Device Identifier: 00849111000277
• UDI-Public: 00849111000277
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/02/2025

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: 8700-0700-01-66
• 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: 01/08/2025
• Supplement Date Received by Manufacturer: 03/12/2025
• Initial Report FDA Received Date: 01/29/2025
• Supplement Report FDA Received Date: 04/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/28/2011
• 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