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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

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

Event Date 12/13/2018

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the product for investigation.A supplemental report will be filed when the product is returned and investigation has been completed.

Event Description

During patient use, customer reported that the autopulse platform (serial # (b)(4)) displayed "system error, out of service, revert to manual cpr " upon powering on.Error message could not be cleared by the user.No known impact or consequence to patient was reported.

Manufacturer Narrative

The reported complaint of the autopulse platform (serial # (b)(4) displayed a "system error, out of service, revert to manual cpr" error message was confirmed during functional testing and archive data review.The investigation findings revealed that the root cause of the reported error message was due to a defective drivetrain motor which is likely attributed to wear and tear.No physical damage was observed on the returned autopulse platform during visual inspection.During device archive data review, latched error 139 (unable to hold compression position) was observed on the reported event date.Thus, confirming the reported complaint.Initial functional testing could not be performed due to "system error, out of service, revert to manual cpr" error message displayed on the autopulse platform during power on.Ap vision 3 software was used to clear "system error, out of service, revert to manual cpr".However, after clearing the error, ua17 (motor on for too long during active operation) displayed during functional testing.To remedy the ua17, the defective drivetrain motor was replaced.Ua17 error message was related to latched error 139 (unable to hold compression position) because both errors were due to similar failure mode found.After part replacement , the autopulse platform was re-evaluated.Platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with known good batteries until discharged without any fault or error.The autopulse platform passed all the functional tests and is ready for clinical use.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint for autopulse with serial # (b)(4).

• Brand Name: AUTOPULSE® PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 8213526
• MDR Text Key: 132386349
• Report Number: 3010617000-2018-01285
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/10/2019

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: 8700-0700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2019
• Initial Date Manufacturer Received: 12/13/2018
• Initial Date FDA Received: 01/03/2019
• Supplement Dates Manufacturer Received: 03/22/2019
• Supplement Dates FDA Received: 04/10/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1