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

Model Number MODEL 100

Device Problems Device Displays Incorrect Message (2591); Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 03/19/2018

Event Type  malfunction  

Manufacturer Narrative

The report of user advisory (ua) 17 (max motor on time exceeded) error message was confirmed through evaluation of the autopulse platform (sn (b)(4)) and archive data review.Functional testing of the platform revealed a (ua) 17 error message on the user control panel during test with normal manikin; the root cause was attributed to a defective drive train motor.The autopulse platform is a reusable device and was manufactured in 2011.Based on the manufactured date the platform has also exceeded its expected service life of 5 years.A review of the autopulse platform's archive was performed and multiple user advisory (ua) 17 messages were observed, thus confirming the customer's reported complaint.As part of routine service during testing, the platform was examined and found damaged load plate cover.The observed physical damages are unrelated to the reported event.After replacement of the drive train motor and the load plate cover, the platform was further tested to full specification including the load characterization check and passed without any further issue observed.Historical records 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

The autopulse platform (sn (b)(4)) displayed a user advisory (ua) 17 (max motor on time exceeded during active operation) error message during testing.No patient was involved with this event.

• 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: 7488733
• MDR Text Key: 107585817
• Report Number: 3010617000-2018-00508
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/04/2018

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: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/04/2018
• Initial Date FDA Received: 05/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2011
• 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