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 06/15/2020

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the lcd display on the autopulse platform (serial #(b)(4)) does not work was confirmed during functional testing and visual inspection.The investigation findings revealed intermittent distorted characters on the lcd display.The root cause of the distorted characters lcd display issue was due to a damaged membrane keyboard, possibly attributed to mishandling such as drop.The patient's vomit on the display did not contributed to the distorted characters display.To remedy the display issue, the user interface membrane switch assembly was replaced.Unrelated to the reported complaint, the autopulse's encoder drive shaft does not rotate smoothly, exhibits binding and resistance.The root cause was due to a sticky clutch plate likely attributed to wear and tear.The returned autopulse platform was manufactured in december 2011 and it is over 9 years old, well past beyond the expected serviceable life of 5 years.Deburring was performed to remedy the sticky clutch plate.The autopulse passed the initial functional test without any fault or error.After service repair completion, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test battery until discharged without any fault or error.The load cell characteristic test passed.The autoplatform platform passed all other functional tests.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaints reported for autopulse with serial number (b)(4).

Event Description

During shift check, customer reported that the lcd display on the autopulse platform (serial #(b)(4)) does not work.Per reporter, a patient had vomited on the display screen on a previous call.No patient involvement.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, ca ; 4192922
• MDR Report Key: 10255589
• MDR Text Key: 198365955
• Report Number: 3010617000-2020-00687
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000130
• UDI-Public: 00849111000130
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/09/2020

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: 8700-0700-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/15/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2020
• Initial Date FDA Received: 07/09/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1