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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

The customer's reported complaint of autopulse displayed two user advisories error messages was confirmed during archive review and during functional testing.The platform failed the initial functional testing due to user advisory (ua) 27 (encoder fault (>3000 rpm)) error message.Encoder gearbox was replaced to remedy the fault.A review of the autopulse platform's archive was performed and the archive showed multiple user advisory (ua) 27 (encoder fault (>3000 rpm)) and user advisory (ua) 34 (encoder failure) occurring on the reported event date due to the encoder failure.As part of routine service during testing, the platform was examined and found physical damage on load plate cover, unrelated to the reported event.After replacement of the load plate cover, the platform was further tested without any further issue observed.The autopulse platform is a reusable device and was manufactured in 2007 and has exceeded its expected service life of 5 years.Therefore, this type of physical damage found during visual inspection is characteristic of normal wear and tear for the life of the device.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

As reported, during patient use, the autopulse platform ((b)(4)) stopped compressions and displayed two user advisories.According to the customer, the error messages were not clearable even after the patient was re-positioned.Manual cpr was immediately performed for an unspecified amount of time.No known impact or patient consequence was reported.No further information was provided.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• 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: noemi schambach ; 2000 ringwood ave; san jose, CA 95131 ; 4084192955
• MDR Report Key: 7607167
• MDR Text Key: 111345136
• Report Number: 3010617000-2018-00635
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000277
• UDI-Public: 00849111000277
• 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: Health Professional
• Type of Report: Initial
• Report Date: 06/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2018
• 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: 05/25/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/18/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/02/2007
• 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