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	03/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint that "the autopulse platform (sn (b)(4) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message immediately upon powering on" was confirmed during functional testing and review of the archive data.The root cause of the (ua) 07 advisory message was the defective load cell modules, likely attributed to mishandling.The observed cracked front cover indicated that the platform was dropped by the user which likely damaged the load cell component.Upon visual inspection, unrelated to the reported complaint, crack was observed on the front cover at the front end area and the top cover had a crack from the inside of the platform.The observed physical damage appeared to be characteristic of user mishandling.The front and top cover will be replaced to address the observed physical damage.A review of the archive data showed multiple (ua) 07 around the event date; thus, confirming the reported complaint.The autopulse platform failed functional testing due to the (ua) 07 advisory message displaying upon powering up the platform, thus, confirming the reported complaint.The load sensing system detected a weight/load imbalance between the two load cells.The load cell characterization test indicated that both load cell modules were defective (the output reading values are over-reporting).The load cell modules 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 was no similar complaint reported for autopulse platform with serial number (b)(4).
Event or Problem Description
During shift check, the customer reported the autopulse platform(sn (b)(4) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message immediately upon powering on.The customer replaced the lifeband but the platform again displayed (ua) 07 upon powering on.No patient involvement.

• 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: 14060426
• Report Number: 3010617000-2022-00328
• Device Sequence Number: 4620980
• Product Code: DRM
• UDI-Device Identifier: 00849111000574
• UDI-Public: 00849111000574
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/08/2022

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: 8700-0730-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2022
• Initial Report FDA Received Date: 04/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/11/2015
• 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