MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE RESUSCITATION MODEL 100; CARDIAC CHEST COMPRESSOR

Model Number MODEL 100

Device Problem Display Difficult to Read (1181)

Patient Problem Insufficient Information (4580)

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.Date of event is unknown.

Event Description

As reported, the user observed that the lcd screen on the autopulse platform (sn: (b)(4)) was unreadable.Patient use information was requested but no additional information was provided, therefore, patient use is unknown.

Manufacturer Narrative

The reported complaint of the lcd screen on the autopulse platform (sn (b)(6) was unreadable, was confirmed during visual inspection.The root cause of the lcd issue was due to a defective processor board in which is likely attributed to normal wear and tear.The returned platform was manufactured in april 2014 and it is almost 7 years old, well beyond its expected service life of 5 years.No other physical damage was observed on the returned autopulse platform.Upon further visual inspection of the platform, noted the fluid ingress contamination under the switch assembly membrane likely due mishandling.This observation is not related to the reported event.The switch assembly membrane was replaced to address the issue.The autopulse platform failed the initial functional test due to intermittent lcd failure and the platform is unable to boot, thus confirming the customer complaint.The defective processor board was replaced to address the reported issue.Unable to download archive data due to the defective processor board.After service repair, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with a good known test battery until discharged without any fault or error.The autopulse platform passed all functional tests.Historical complaints were reviewed for service information related to the reported complaint, and there was no similar complaint reported for autopulse with serial number (b)(6).

• Brand Name: AUTOPULSE RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 11009541
• MDR Text Key: 221525409
• Report Number: 3010617000-2020-01254
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000130
• UDI-Public: 00849111000130
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 01/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/15/2020
• 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: 8700-0700-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2020
• Date Manufacturer Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1