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

Model Number MODEL 100

Device Problem Failure to Power Up (1476)

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

Event Date 03/03/2022

Event Type  malfunction  

Manufacturer Narrative

During device evaluation performed at zoll, the returned autopulse platform (s/n (b)(4)) failed to power up.The root cause of the noted failure was the defective motor controller and processor boards, caused by blood/fluid ingress into the autopulse platform, probably attributed to user mishandling.Both the motor controller and processor boards were replaced to remedy the fault.During further inspection, it was noted that the lcd screen was unreadable due to the blood/fluid ingress.The defective lcd screen assembly was replaced to address the issue.Visual inspection was performed on the returned autopulse platform, and no apparent physical damage was observed.During open case inspection, the front and bottom enclosures were removed, and a massive amount of blood and fluid ingress was found inside the autopulse platform, consistent with the customer's statement that "the platform was contaminated with blood/body fluid." the contamination had formed corrosion on the top cover metalized inner surface.Replacement of the top cover and complete reassembly of the platform was needed to address the issue.Subsequently, the autopulse platform was bio-cleaned.Following service, the autopulse platform was subjected to a final run-in test using the 95% large resuscitation test fixture (lrtf) with known good test batteries until discharged 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)(4).

Event Description

During device evaluation performed at zoll, the returned autopulse platform (s/n (b)(4)) failed to power up, and the lcd screen was unreadable.No patient involvement.

• 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: 13865347
• MDR Text Key: 287785877
• Report Number: 3010617000-2022-00296
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: 03/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2008
• 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