MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE PLATFORM RESUSCITATION; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

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

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

Event Date 05/10/2021

Event Type  malfunction  

Manufacturer Narrative

During investigation performed at zoll, the lcd screen of the returned autopulse platform (s/n (b)(4)) was not readable in the dark by the zoll service personnel.The root cause of the observed issue was the defective processor board, likely due to wear and tear.The autopulse platform was manufactured in (b)(6) 2013, and it is over 7 years old, beyond its expected service life of 5 years.During visual inspection of the returned autopulse platform, no physical damage was observed.The autopulse platform passed the initial functional test without any fault or error.Load characterization check was performed and verified that both load cells were functioning within the specification.During functional testing, it was noted that the backlight of the display flickered briefly when the platform was powered on, and it went dark afterward.As a result of this, the lcd was unreadable in the dark.During open case inspection, it was noted that the cable connecting the lcd to the processor board was damaged.The lcd was replaced, and the damaged cable issue was resolved; however, the backlight issue persisted.The processor board was replaced to remedy the lcd backlight issue.Following service, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The brake gap inspection was performed and verified the brake gap was within the specification.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaints reported for autopulse platform with serial number (b)(4).

Event Description

During device evaluation of the autopulse platform (s/n (b)(4)), the lcd screen was not readable in the dark by the zoll service personnel.No patient involvement.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• 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: 11918082
• MDR Text Key: 253770625
• Report Number: 3010617000-2021-00514
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• Combination Product (y/n): N
• Reporter Country Code: SZ
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• 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: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/11/2013
• 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