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

Model Number MODEL 100

Device Problems Erratic or Intermittent Display (1182); Display or Visual Feedback Problem (1184)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/23/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform (sn (b)(4)) for investigation.A supplemental report will be filed when the product is returned and the investigation has been completed.

Event Description

The user observed flickering or intermittent functioning of the lcd back light.In addition, the user noticed damage on the bottom enclosure of the autopulse platform (sn (b)(4)) occurred during transit after the previous service repair.No additional information was provided.No known impact or consequence to patient information was provided.

Manufacturer Narrative

The reported complaint of "flickering or intermittent functioning of the lcd back light and damage on the bottom enclosure of the autopulse platform (sn (b)(4)" was confirmed during the functional testing and the visual inspection of the returned platform.The root cause for the lcd backlight issue was due to the damaged processor board as a result of damage sustained by harsh impact.Upon visual inspection, observed damage on the bottom enclosure.The cause for the physical damage was due to the harsh impact, which occurred during the device transit.The bottom enclosure was replaced to remedy the damage.During functional testing, the autopulse platform performed compressions without any error or fault.Observed intermittent functioning of the lcd back light, thus confirming the reported complaint.The processor board was replaced to remedy the lcd problem.The archive data review showed no significant discrepancies.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 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.The autopulse platform passed the final testing without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with sn (b)(4).

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 9079423
• MDR Text Key: 158989318
• Report Number: 3010617000-2019-00801
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• 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,distri
• Type of Report: Initial,Followup
• Report Date: 12/12/2019

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: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2019
• Initial Date Manufacturer Received: 08/23/2019
• Initial Date FDA Received: 09/17/2019
• Supplement Dates Manufacturer Received: 11/22/2019
• Supplement Dates FDA Received: 12/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1