MAUDE Adverse Event Report: ZOLL CIRCULATION 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	Insufficient Information (4580)
Date of Event	07/31/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the product for investigation.A follow-up report will be submitted when the product is returned, and investigation has been completed.
Event or Problem Description
During patient use, customer reported that the autopulse platform (serial #31331) displayed user advisory "(ua) 45" (driveshaft not at "home" position after power-on/restart) error message.Patient's status information was requested but the customer did not provide a response.
Additional Manufacturer Narrative
The customer's complaint that the autopulse platform (sn (b)(6)) displayed user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) message was confirmed during the functional testing and the archive data review.The root cause of the ua45 advisory message was that the driveshaft was not in the "home" position, which was most likely attributed to unintended user error.The autopulse functioned as intended by triggering ua45 when the driveshaft was not at the "home" position.Unrelated to the reported complaint, a broken screw holder on the front enclosure was noted upon visual inspection.The observed physical damage was likely attributed to user mishandling.The front enclosure was replaced to address the observed physical damage.The archive data indicated multiple ua45 messages around the reported event date, confirming the reported complaint.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), and then restart.Upon clearing the ua, the autopulse platform was subjected to a run-in test using the large resuscitation test fixture (lrtf) with known good test batteries until discharged without fault or error.The autopulse platform failed functional testing due to ua45 displayed upon powering up, confirming the reported complaint.It was noted that the lifeband was cut before it was removed correctly, allowing the cut ends to unwind without the drive shaft being rotated.The driveshaft was rotated to the "home" position to remedy the fault.Upon further inspection, unrelated to the reported complaint, the backlight of the lcd was found to be flickering upon powering on, and the screen went dark afterward.The processor pca board was replaced to address the flickering backlight problem.Upon clearing the ua45, the autopulse platform passed the testing and functioned as intended.A load cell characterization test confirmed that both cell modules function within the specification, and the brake gap inspection was performed and verified the brake gap was within the specification.Following service, 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).

• 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: kim nguyen ; 2000 ringwood ave; san jose, CA 95131
• MDR Report Key: 17621159
• Report Number: 3010617000-2023-00706
• Device Sequence Number: 14943064
• Product Code: DRM
• UDI-Device Identifier: 00849111000598
• UDI-Public: 00849111000598
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• 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): 12/09/2023

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: 8700-0730-11
• 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: 07/31/2023
• Supplement Date Received by Manufacturer: 11/13/2023
• Initial Report FDA Received Date: 08/25/2023
• Supplement Report FDA Received Date: 12/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2010
• 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