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

Model Number MODEL 100

Device Problem No Display/Image (1183)

Patient Problem No Patient Involvement (2645)

Event Date 12/06/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has received the platform however, the investigation is pending.A follow-up report will be submitted when the investigation has been completed.

Event Description

During shift check, customer reported that the display screen on the autopulse platform (serial #(b)(4)) was blank and was not readable.No patient involvement.

Manufacturer Narrative

The reported complaint of a blank screen display on the autopulse platform (serial # (b)(4) was confirmed during functional testing.The investigation findings revealed that the probable cause of the reported error was due to a defective system processor board which may likely sustained during mishandling because of damaged observed on the device.During visual inspection, a damaged front enclosure on the returned autopulse platform was observed.This type of physical damaged observed on the autopulse platform was due to mishandling and relevant to the reported complaint.The front enclosure was replaced.Initial functional testing of the returned autopulse platform confirm blank screen.To remedy the display issue, the defective system processor board was replaced.After part replacement, the autopulse was re-evaluated.Platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with known good batteries until discharged without any fault or error.The autopulse platform passed all the functional tests.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint for autopulse with serial # (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: 9535793
• MDR Text Key: 179427346
• Report Number: 3010617000-2019-01154
• 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,health
• Type of Report: Initial,Followup
• Report Date: 01/29/2020

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: 8700-0730-01
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/23/2019
• Initial Date Manufacturer Received: 12/06/2019
• Initial Date FDA Received: 12/31/2019
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 01/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1