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

Model Number MODEL 100

Device Problems Display Difficult to Read (1181); Display or Visual Feedback Problem (1184)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/07/2024

Event Type  malfunction  

Event Description

The customer reported that the lcd screen of the autopulse platform (b)(6) was unreadable.No further information was provided.It is unknown when the problem occurred.However, patient use information was requested, but no additional information was provided.

Manufacturer Narrative

The reported complaint of the lcd screen of the autopulse platform (b)(6) being unreadable was confirmed during a visual-functional inspection.The root cause of the reported complaint was the malfunctioning lcd transmissive board, likely attributed to the age of the device.The autopulse platform was manufactured in (b)(6) 2010 and is over 14 years old, well beyond its expected service life of 5 years.Visual inspection of the returned autopulse platform revealed that the top cover, front enclosure, battery compartment, bottom enclosure, and battery lock were damaged, unrelated to the reported complaint.The exterior of the top cover had hairline cracks, and its interior had broken screw bosses.There was a vertical crack going through one of the screw fittings of the front enclosure.The exterior of the battery compartment and the interior of the bottom enclosure had broken screw bosses.Also, the battery lock was twisted.The minor cracks could have resulted from wear and tear, and the twisted battery lock and broken pieces appeared to be the characteristics of harsh impacts due to user mishandling.The damaged parts must be replaced to address the issues.Review of the autopulse platform's archive data did not reveal any significant discrepancies or error messages.Upon the initial functional testing, the autopulse platform powered up without fault or error.The lcd screen was unreadable with missing pixels due to the malfunctioning lcd transmissive which was replaced with a known-good service part to resolve the issue.Subsequently, the autopulse platform successfully passed a run-in test using the large resuscitation test fixture (lrtf) for about 15 minutes.Zoll is awaiting the customer's approval for repair.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).

Manufacturer Narrative

During servicing of the autopulse platform, it was noted that the platform's on/off power button was cut, most likely attributed to overtime use of the device (wear and tear) or mishandling.This physical damage did not affect the platform's functionality.Following service, a brake gap inspection was performed and verified the brake gap was within the specification.A load cell characterization test was performed and confirmed that both cell modules were functioning within the specification.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.

Event Description

The customer reported that the lcd screen of the autopulse platform (sn (b)(6) ) was unreadable during routine equipment checks.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 sackrison ; 2000 ringwood ave.; san jose, CA 95131 ; 4084192922
• MDR Report Key: 19000558
• MDR Text Key: 338926841
• Report Number: 3010617000-2024-00274
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000772
• UDI-Public: 00849111000772
• 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,Followup
• Report Date: 04/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2024
• 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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/11/2010
• 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