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 Issue (2379); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 04/20/2018

Event Type  malfunction  

Manufacturer Narrative

The reported event was confirmed through evaluation and archive data review of the autopulse platform (sn (b)(4)).The root cause is due to a defective load cell.Visual inspection was performed and observed a damaged top cover.The physical damage found during visual inspection is not related to the reported event.The archive data was reviewed and contained user advisory (ua) 02 (compression tracking error) on (b)(6) 2018 confirming the reported event.In addition ua45 shaft not at "home" position occurred.The lifeband straps were not pulled completely out prior to turning the device on.) error message also occurred on the reported event date which is not related to the reported event.Upon evaluation of the platform, load characterization check was performed and identified a defective load cell.Further functional testing was performed by replacing a good known load cell, this cleared the ua2 error message; however, the platform displayed a ua 27 (drive shaft turning too fast during compression) error message occurred within 5-10 compression, this is due to defective gearbox and not related to the reported event.The autopulse platform is a reusable device and was manufactured on 24 mar 2011.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints reported for autopulse platform serial number (b)(4).

Event Description

During shift check, the autopulse platform (sn (b)(4)) displayed user advisory 02 (compression tracking error) and was not able to clear by the user.No patient involvement.

• 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: kimthoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 7527674
• MDR Text Key: 108730195
• Report Number: 3010617000-2018-00566
• 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: Other
• Type of Report: Initial
• Report Date: 05/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/18/2018
• 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: 8700-0700-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2011
• 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