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

Model Number	100
Medical Device Problem Codes	Use of Device Problem (1670); Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The customer reported that during device checks, they observed that one side of the lifeband does not securely clip into the autopulse platform (sn (b)(6)).They tried installing a different lifeband, but the same problem occurred.The autopulse platform appears to function properly when used with a manikin.Zoll territory manager (representative) checked the platform's locking tabs and could not see any damage.No patient involvement.
Additional Manufacturer Narrative
Zoll has not received the autopulse platform in complaint for investigation.A follow-up report will be filed if and when the product is returned and investigation has been completed.
Additional Manufacturer Narrative
Sections d9, h3, h4, and h6 codes were updated.The reported complaint that one side of lifebands would not securely clip into the autopulse platform (sn (b)(6) was not confirmed during functional testing.The autopulse platform functioned as intended.Reviewing the archive data revealed several user advisory 45 (not at "home" position after power-on/restart) events that were not reported by the customer.The lifeband may not have been pulled up completely prior to turning the device on.The ua45 was not replicated during testing at zoll, meaning that the customer had been able to clear the ua45.User advisory is normally a clearable error message and is designed into the autopulse 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 passed initial functional testing without any fault or error.A known-good zoll service lifeband was attached to the autopulse platform.The lifeband seated properly without any issues.The platform was then shaken several times, and the lifeband cover plate remained securely attached to the platform's die-cast channel.There were no dimensional or mechanical issues with the die-cast channel that may have caused or contributed to the reported complaint.The reported complaint was not confirmed.Zoll is awaiting the customer's approval for the service fee.

• 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: 23408402
• Report Number: 3010617000-2025-00754
• Device Sequence Number: 15635243
• Product Code: DRM
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 07/13/2026

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: 8700-0700-01
• 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: 10/09/2025
• Supplement Date Received by Manufacturer: 06/18/2026
• Initial Report FDA Received Date: 10/28/2025
• Supplement Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2011
• 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