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 Patient Involvement (2645)

Event Date 05/01/2020

Event Type  malfunction  

Manufacturer Narrative

The device associated with this complaint has been received, however, the investigation is pending.A follow up report will be filed when the investigation has been completed.

Event Description

During the shift check, the customer reported that the autopulse platform (sn (b)(4)) does not power on.The lcd display is blank, however, the backlight is illuminating.After pressing the menu/mode switch button, the lcd displays 'waiting to communicate' message.No patient involvement.

Event Description

During shift check and upon powering on, the customer noticed that the lcd display of the autopulse platform (sn (b)(4) was blank, however, the back-light was illuminating.After pressing the menu/mode switch button, the platform made a clicking sound and the lcd displays 'waiting to communicate' message.No patient involvement.

Manufacturer Narrative

The reported complaint of "the blank screen or back-light illuminating on the lcd display of the autopulse platform (sn (b)(4) and after pressing the menu/mode switch button, the platform made a clicking sound and the lcd displays 'waiting to communicate' message" was confirmed during functional testing.The root cause was due to the defective processor board, most likely as a result of normal wear and tear.The autopulse platform was manufactured in june 2011 and is more than 9 years old, well beyond the expected service life of 5 years.Visual inspection of the returned platform revealed a bent battery lock.The observed physical damage was unrelated to the reported complaint, and the root cause could be due to normal wear and tear and/or due to user mishandling.The damaged battery lock was replaced to remedy the issue.The data archive could not be recovered for review due to the defective processor board.The platform failed to power on during initial functional testing due to a defective processor board.Although the customer reported problem was not exactly duplicated during the testing, the defective processor board is the root cause for all the reported issues and was confirmed during the functional testing, because the platform failed to power on.The processor board was replaced to remedy the issue.Following the service repair, the platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries for 15 minutes without any fault or error.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse platform with serial number (b)(4).

• Brand Name: AUTOPULSE RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 10084469
• MDR Text Key: 192476326
• Report Number: 3010617000-2020-00527
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 06/19/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Date Manufacturer Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1