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

Model Number MODEL 100

Device Problem Display Difficult to Read (1181)

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

Event Type  malfunction  

Manufacturer Narrative

The report of the lcd panel intermittently displayed unreadable characters on the autopulse platform (sn: (b)(4)) was not confirmed during functional testing, and visual inspection.The platform performed as intended.No device malfunction was observed during the testing.During the visual inspection, no issues were observed.During the archive data review, no significant discrepancy was identified.During functional testing, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries without any lcd issue, fault or error.The load cell characterization test was performed and confirmed both cell modules were functioning within the specification.As a precautionary measure, the lcd and the processor board were replaced.The autopulse platform is a reusable device, and was manufactured in august 2016, and it is nearing the expected serviceable life of 5 years.After the service, the autopulse platform 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 autopulse platform passed the final testing without any fault, or error.Date of event is unknown.

Event Description

During device check, the autopulse platform (sn: ((b)(4)) displayed unreadable characters when powered on.The lcd issue was noted intermittently.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: 10805947
• MDR Text Key: 215332427
• Report Number: 3010617000-2020-01116
• 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,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2020
• 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: 10/15/2020
• Date Manufacturer Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2016
• 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