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 Operates Differently Than Expected (2913)

Patient Problem No Patient Involvement (2645)

Event Date 12/07/2016

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (s/n: (b)(4)) was returned to zoll for evaluation.The primary complaint of user advisory (ua) 45 (not at "home" position after power-on/restart) error message was confirmed during evaluation.The error message appeared upon powering on the platform.Review of the archive data confirmed that ua 45 error had occurred on the reported date of event.Based on the archive data, the drive shaft is not at the home position and this typical fault occurs when the user did not pull up the lifeband completely before powering on the platform.This user advisory will persist until the driveshaft is returned to its home position.Per the autopulse user guide instruct, to clear ua 45, the operator needs to pull up the lifeband until the chest bands are full extended.This action will move the driveshaft to its home position.Visual inspection was performed and found (unrelated to the reported complaint) cracks to the top, front, and bottom covers.The autopulse platform is a reusable device and was manufactured on 09/14/2011.Therefore, this type of physical damages is characteristic of normal wear and tear for the life of the device.The damaged parts observed during visual inspection were replaced.To resolve the issue, the driveshaft was returned to the home position.The autopulse was functionally tested and passed without errors.The platform passed all final testing criteria.Device history record (dhr) was reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).

Event Description

It was reported that the autopulse platform (s/n: (b)(4)) displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) error message.According to the reporter, attempts were made to resolve the issue, however, the problem continued.There is no patient involvement reported.

• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 6214382
• MDR Text Key: 63624625
• Report Number: 3010617000-2016-00952
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: health professional,user faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/29/2016

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/07/2016
• Initial Date FDA Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/14/2011
• 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