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

Model Number MODEL 100

Device Problems Display Difficult to Read (1181); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 05/15/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (sn (b)(4)) showed lines on the user control panel and the platform made clicking sound was not confirmed during initial functional testing.The autopulse platform was powered on successfully and no lines on the display or clicking sound were observed during the testing.Unable to duplicate the customer reported complaint.There was no physical damage observed on the returned autopulse platform during the visual inspection.During initial functional testing, the autopulse platform was powered on successfully.No other device malfunction was observed.The date and time in the archive log was corrupted due to a damaged processor board as a result of wear and tear, unrelated to the reported complaint.The returned autopulse platform was manufactured in march 2008 and it is more than 12 years old, well beyond its serviceable life of 5 years.The processor board was replaced to address the observed issue.Following 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.

Event Description

During the device check, the autopulse platform (sn (b)(4)) was observed with lines on the user control panel, and platform made a clicking sound.User was not able to read the display.The user tested the platform with another battery, however, the issue persists.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
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, ca ; 4192922
• MDR Report Key: 10132164
• MDR Text Key: 194446025
• Report Number: 3010617000-2020-00570
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2020

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/15/2020
• Initial Date FDA Received: 06/09/2020
• 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