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

Model Number	MODEL 100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's complaint that the autopulse platform (sn (b)(6)) was "extremely hot to the touch of a hand" was confirmed during the archive data review but not during the functional testing at zoll.The archive data indicated that the internal temperature was high during the reported event.The investigation revealed no device malfunction.Therefore, the likely cause of the temperature increase was a blocked cooling vent, attributed to user handling.Per the autopulse resuscitation system model 100 user guide; do not block the vents of the autopulse platform.If airflow through the vents is obstructed, the temperature of the patient surface of the autopulse platform may rise.If the temperature of the patient surface exceeds 45 degrees celsius for more than five minutes, the platform will cease compressions and advise the user to check the vents.Upon visual inspection, no physical damage was observed.The archive data indicated no significant discrepancies other than the maximum internal temperature of 41 degrees celsius, confirming the reported complaint.The autopulse platform passed the functional testing without error or fault, and the reported complaint was not replicated throughout the testing.The autopulse platform functioned as intended.Following service, the brake gap inspection verified the brake gap was within the specification.A load cell characterization test confirmed that both cell modules function within the specification.The autopulse platform passed the run-in and final tests without fault or error.Historical complaints were reviewed for service information related to the reported complaint, and no similar complaint was reported for the autopulse platform with sn (b)(6).
Event or Problem Description
Patient #2: the autopulse platform (sn (b)(6)) was used to resuscitate a patient, and the platform performed compressions for about 25 to 30 minutes with no issues.After the patient's use, the customer noticed that the platform was "extremely hot to the touch of a hand." per the reporter, no device malfunction was observed on the platform during the patient's use, and it functioned as intended.There were no consequences or impacts on the patient.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kimthoa sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19235252
• Report Number: 3010617000-2024-00370
• Device Sequence Number: 8034380
• Product Code: DRM
• UDI-Device Identifier: 00849111065009
• UDI-Public: 00849111065009
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/02/2024

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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 05/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/27/2014
• 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