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

Model Number MODEL 100

Device Problems No Display/Image (1183); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 06/20/2019

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform (serial # (b)(4)) blank screen upon powering on and makes constant clicking noise was confirmed during functional test.The investigation findings revealed that the root cause of the reported blank screen was due to a damaged processor board as a result of wear and tear.The returned autopulse platform was manufactured in march 2008 and it is 11 years old, well beyond its serviceable life of 5 years.Unrelated to the reported complaint, a damaged top cover, channel roller assembly, lcd screen, front and bottom enclosures were observed during visual inspection.The damaged covers and channel roller assembly was likely attributed to wear and tear as a result of an aging device.The damaged lcd screen was likely due to user mishandling.All covers and the lcd screen were replaced to addressed the damaged parts.In addition, the encoder drive shaft does not rotate smoothly, exhibits binding and resistance as a result of a sticky clutch plate.Deburring of the clutch plate was performed to remedy the faulty encoder drive shaft.Initial functional test could not be performed because the ap platform could not be powered on.The damaged processor board was replaced to remedy the power issue.After service was completed, 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 ap platform passed all functional tests and it is ready for clinical use.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)(4).

Event Description

During shift check, customer reported that the display screen on the autopulse platform (serial # (b)(4)) was blank upon powering on and makes constant clicking noise.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 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 8781529
• MDR Text Key: 150852748
• Report Number: 3010617000-2019-00581
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2008
• 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