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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/10/2018

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of user advisory - ua45 (not at "home" position after power-on/restart) on the autopulse platform (serial #21832) was confirmed during functional testing and during archive data review.The investigation findings revealed that the root cause was due to user error.The hospital nurse inadvertently ripped-off the lifeband from the platform and caused the drive shaft not to be at home position.No physical damaged observed on the ap platform during visual inspection.However, the encoder drive shaft does not rotate smoothly, exhibits binding and resistance was identified.This type of faulty drive shaft observed are characteristics of normal wear and tear in relevant of the device age.The autopulse platform is a reusable device and was manufactured on march 2008.The device has been operating for 10 years and has exceeded its expected serviceable life of 5 years.This observation was unrelated to the reported event.The faulty drive shaft was deburred to remedy the issue.During archive data review, multiple ua45 error messages were observed on the date when the reported event occurred.Thus, confirming the reported complaint.Initial functional testing could not be performed due to ua45 (not at "home" position after power-on/restart) displayed when the platform was turned on.Thus, confirming the reported complaint.To remedy the issue, the shaft was rotated to home position by using the administrative menu.The ap platform was re-tested and passed all functional tests.The platform is ready for clinical use.Historical records were reviewed for service information related to the reported complaint and there were no similar complaints reported for autopulse with serial number (b)(4).

Event Description

During patient use, customer reported that the autopulse platform (serial #: (b)(4)) displayed user advisory - ua45 (not at "home" position after power-on/restart) error message immediately right after when the hospital nurse inadvertently ripped-off the lifeband.After the incident, customer claimed that the platform was not functioning properly.No known impact or consequence to patient was reported.

• 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: 8211049
• MDR Text Key: 132294243
• Report Number: 3010617000-2018-01280
• 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: 01/02/2019

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/10/2018
• Initial Date FDA Received: 01/02/2019
• 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