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 Consequences Or Impact To Patient (2199)

Event Date 09/18/2019

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 autopulse platform (sn (b)(4)) lcd screen displayed bright and dark pixels like a chessboard upon powering on.The lcd display was unreadable.Procamed tested the autopulse platform several times, however the lcd problem could not be reproduced.No known impact or consequence to patient information was provided.

Manufacturer Narrative

The reported complaint of "autopulse platform (sn (b)(4) lcd screen displayed bright and dark pixels upon powering on" was confirmed during the visual inspection.The root cause for the reported complaint was due to the defective lcd screen as a result of normal wear and tear of the platform.The platform was manufactured on 2012, and is almost 7 years old, past the expected service life of 5 years.Upon visual inspection, the lcd screen displayed missing pixels upon powering on, thus confirming the reported complaint.No other physical damage was observed.The autopulse platform passed the initial functional testing without any fault or error.Upon customer approval, the defective part will be replaced and the autopulse platform will be further tested to full specification.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: 9175559
• MDR Text Key: 162497462
• Report Number: 3010617000-2019-00892
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001038
• UDI-Public: 00849111001038
• 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: 10/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2019
• 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: 10/15/2019
• Date Manufacturer Received: 10/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1