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	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported the autopulse lifeband locking tab slots on the autopulse platform (sn (b)(6)) were observed to be broken.The issue affects the functionality of the platform.The issue was observed after patient use.During the call, the platform performed as intended.No patient involvement.
Additional Manufacturer Narrative
Zoll has not yet received the autopulse platform in the complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Additional Manufacturer Narrative
The customer's complaint of the autopulse lifeband locking tab slots on the autopulse platform (sn (b)(6)) were observed to be broken was confirmed during the visual inspection.The locking tabs of the lifeband cover plate on the front and bottom enclosure were damaged.These locking tabs secure the lifeband cover plate to the channel (die-cast) of the autopulse platform.Most likely, the damaged locking slots did not allow the customer to fully connect the lifeband to the platform.The observed physical damages appeared to be the characteristics of harsh impact due to user mishandling, such as a drop.The front and bottom enclosures were replaced to address the reported complaint.During further visual inspection, unrelated to the reported complaint, damage on the top cover was observed.This physical damage was likely attributed to mishandling such as a drop.The top cover was replaced to address the observed damage.The archive data review showed no significant discrepancies.The autopulse platform passed the initial functional test without any fault or error.Following service, the autopulse platform passed the run-in test 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 similar complaint 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: kimthoa sackrison ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19397583
• Report Number: 3010617000-2024-00427
• Device Sequence Number: 12698787
• Product Code: DRM
• UDI-Device Identifier: 00849111000772
• UDI-Public: 00849111000772
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/05/2024

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: 8700-0730-01-66
• 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: 05/01/2024
• Supplement Date Received by Manufacturer: 05/29/2024
• Initial Report FDA Received Date: 05/24/2024
• Supplement Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2020
• 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