MAUDE Adverse Event Report: ZOLL CIRCULATION, INC. AUTOPULSE®RESUSCITATION SYSTEM; CARDIAC RESUSCITATOR, LINE-POWERED

Model Number	100
Medical Device Problem Codes	Display or Visual Feedback Problem (1184); Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported that the autopulse platform (sn: (b)(6) displayed an unknown error code after the lifeband was torn and subsequently after replacing the torn lifeband.Based on functional testing and a review of archive data, the autopulse platform repeatedly displayed user advisory (ua) 45 (not at "home" position after power-on/restart) when powering up around the date of the customer's reported complaint.The ua45 advisory message was replicated during functional testing.The root cause of the ua45 advisory message was that the driveshaft was not in its "home" position, most likely due to unintended user error.The reported complaint that the display screen's light was defective (dark) was confirmed during the visual-functional inspection.The lcd flickered briefly upon powering up the platform and remained dark afterward.However, the lcd was still readable.The root cause of the lcd backlight issue was the defective processor board, which was replaced to resolve the problem.User advisory is normally a clearable advisory message and is 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 (ua) 45 will occur.This user advisory will persist until the driveshaft is returned to its "home" position.To clear the ua45, pull up on the lifeband until the chest bands are fully extended (thereby moving the driveshaft back to its "home" position), and then press restart.The autopulse platform failed initial functional testing due to a ua45 advisory message displayed upon powering up, confirming the reported complaint.The platform's driveshaft was rotated to its "home" position to address the fault.The autopulse platform was then tested intensively with a large resuscitation testing fixture (lrtf) using two fully charged batteries, and no errors appeared.Following service, the autopulse platform passed all testing criteria.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for the autopulse platform with serial number: (b)(6).
Event or Problem Description
The customer reported that during patient use, the autopulse platform (sn: (b)(6) operated without issues for about 20 minutes before the lifeband (lot#: 197739) unexpectedly tore off.Subsequently, an error message appeared on the platform.The customer mentioned that the display screen's light was defective (dark) but still readable.However, they couldn't recall the error code displayed on the lcd screen.The torn lifeband was contaminated with the patient's bodily fluids and needed to be disposed of.The issue occurred on the way to the destination hospital, and the crew immediately continued manual resuscitation.Resuscitation was briefly interrupted to unload the stretcher from the ambulance.No consequences or impacts on the patient.After the call, the customer attempted to put the autopulse platform back into operation.To do this, they had to remove the remains of the torn lifeband from the shaft.The customer stated that the lifeband had apparently torn on the shaft of the platform, where the band is sewn and glued.The adhesive on the lifeband's black hinged belt guards (skirts) that are threaded into the shaft was no longer in good condition, and the seam could not withstand the strain.Based on the picture provided by the customer, the tyvek liner on the lifeband was completely ripped and separated from the lifeband's hinged belt guards.After replacing the lifeband, the autopulse platform immediately displayed an error code.

• Brand Name: AUTOPULSE®RESUSCITATION SYSTEM
• Common Device Name: CARDIAC RESUSCITATOR, LINE-POWERED
• 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 sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192347
• MDR Report Key: 21867996
• Report Number: 3010617000-2025-00283
• Device Sequence Number: 4721691
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 04/18/2025

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: 100
• Device Catalogue Number: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2025
• Initial Report FDA Received Date: 04/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/30/2015
• 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