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

Model Number MODEL 100

Device Problem Device Displays Incorrect Message (2591)

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

Event Date 04/28/2018

Event Type  malfunction  

Manufacturer Narrative

The reported complaint on autopulse platform s/n (b)(4) was confirmed during functional testing.The drive train motor was replaced to resolve the reported issue.No physical damage observed upon receipt.Upon powering on the platform, unable to perform initial functional testing due to system error message displayed.The platform's archive showed a system error 139 - unable to hold compression position occurred on (b)(6), the date reported by the customer.The fault was due to the drive train motor brake assembly air gap was too wide, out of specification at (0.011").The drive train motor was replaced to remedy the complaint.The platform was re-evaluated through run_in test without any fault or error.The autopulse has passed all the testing and meets all required specifications.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of similar complaints for autopulse sn (b)(4).

Event Description

It was reported that a patient in cardiac arrest was initiated manual cpr.Upon deployment of the autopulse platform (sn (b)(4)), a "system error, out of service, revert to manual cpr " message was displayed on the user control panel.Following this, manual cpr was resumed for an unspecified amount of time.It was further reported that the patient achieved rosc at the hospital.No known impact or patient consequence was reported.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR,
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer Contact: kim nguyen ; 2000 ringwood avenue; san jose, CA 95131
• MDR Report Key: 7554923
• MDR Text Key: 109632311
• Report Number: 3010617000-2018-00511
• 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: Health Professional
• Type of Report: Initial
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2018
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/01/2018
• 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