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

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has received the autopulse platform for investigation.A supplemental report will be submitted when the investigation has been completed.
Event or Problem Description
During shift check, the customer reported that the autopulse (sn (b)(6)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) upon powering on the platform.No patient involvement.
Additional Manufacturer Narrative
The reported complaint that " the autopulse platform(sn (b)(6) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) " was confirmed during functional testing and review of the archive data.The root cause of the (ua) 07 was due to the failure of single point load cell #1, likely attributed to failed component(s), or mishandling such as a drop.Visual inspection of the returned platform was performed, and no physical damage was observed.A review of the archive data showed (ua) 07; thus, confirming the reported complaint.The platform failed initial functional testing due to the (ua) 07 advisory message displayed upon powering up the platform; thus, confirming the reported complaint.Single point load cell #1 will be replaced to remedy the complaint.Zoll is awaiting customer approval for service repair.Historical complaints were reviewed for service information related to the reported complaint and there were no similar complaints reported for autopulse with serial number (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: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 17337221
• Report Number: 3010617000-2023-00628
• Device Sequence Number: 15107522
• Product Code: DRM
• UDI-Device Identifier: 00849111002530
• UDI-Public: 00849111002530
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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): 08/15/2023

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-14
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/29/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2023
• Supplement Date Received by Manufacturer: 08/08/2023
• Initial Report FDA Received Date: 07/17/2023
• Supplement Report FDA Received Date: 08/15/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2021
• 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