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

Model Number MODEL 100

Device Problems Display or Visual Feedback Problem (1184); Noise, Audible (3273)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/07/2022

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of "all leds on the platform and the lcd backlight lit up, but the platform made a clicking noise and the lcd screen was blank" was not confirmed during testing at zoll.After the autopulse platform powered on, the lcd displayed was clear and readable (not blank), and the zoll service engineer did not report hearing any sort of clicking sound.During visual inspection, multiple cracks were observed on the top cover near the load plate cover.In addition, there was a vertical crack going through one of the screw fittings at the front-end area of the front enclosure, and there were multiple cracks in the screw well area of the bottom enclosure.The noted physical damages are unrelated to the reported complaint and are characteristics of harsh impacts due to user mishandling.All the damaged covers were replaced to address the issues.The customer was concerned if blood may have entered the platform during patient treatment at the hospital.The zoll service engineer removed both the front and bottom enclosures but did not observe any traces of blood ingress.The archive data review showed the occurrence of system error - 132 (internal watchdog timeout), unrelated to the reported complaint.The autopulse platform failed initial functional testing due to "system error, out of service, revert to manual cpr" displayed upon powering up, unrelated to the reported complaint.Technical investigation revealed that the root cause of the system error was the defective processor board, possibly due to a defective component.The processor board was replaced to remedy the fault.Following service, the autopulse platform was subjected to a run-in test using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged without any fault or error.

Event Description

The customer reported that the patient did not meet the indications for autopulse use, but the paramedic placed the patient on the autopulse platform (s/n (b)(4) proactively.The paramedic did not have to use the platform during transport to the hospital because the patient did not experience cardiac arrest.The crew members stated that blood may have entered the platform during patient treatment at the hospital.After returning to the station, the autopulse platform did not function as intended.When the autopulse was powered on, all leds on the platform and the lcd backlight lit up, but the platform made a clicking noise and the lcd screen was blank.No consequences or impacts on the patient.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: 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 thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 15342315
• MDR Text Key: 302843052
• Report Number: 3010617000-2022-01483
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/01/2022

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
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2022
• Initial Date FDA Received: 09/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1