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 Patient Involvement (2645)

Event Date 05/21/2020

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 08 june 2020 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

During shift check, the autopulse platform (sn: (b)(4)) displayed "system error, out of service, revert to manual cpr" error message.No patient involvement.

Manufacturer Narrative

H3 (device evaluated by manufacturer) was corrected.

Manufacturer Narrative

D10 (date returned to manufacturer) was corrected.The reported complaint of the autopulse platform (sn: (b)(6)) displayed "system error, out of service, revert to manual cpr" error message was confirmed during the archive data review and functional testing.The root cause of the reported complaint was a defective processor board, likely due to a defective component.Visual inspection of the retuned autopulse platform revealed a cracked front enclosure at the front-end area of the platform.The observed physical damage is not related to the reported complaint, and the root cause is most likely attributed to user mishandling.The front enclosure will be replaced to address the issue.The archive data review showed the occurrence of system error - user advisory (ua) 132 (internal watchdog timeout) around the customer's reported event date; thus, confirming the reported complaint.The autopulse platform failed initial functional testing due to "system error, out of service, revert to manual cpr" error message displayed upon powering up the device.Therefore, the reported complaint was confirmed.The defective processor board (pca) will be replaced to remedy the fault.Awaiting customer's approval for repair.Historical complaints were reviewed for service information related to the reported complaint, and there was no previous history of complaint reported for autopulse with serial number (b)(6).

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 10197912
• MDR Text Key: 197406511
• Report Number: 3010617000-2020-00630
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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,health
• Type of Report: Initial,Followup,Followup
• Report Date: 07/21/2020

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: 06/29/2020
• Initial Date Manufacturer Received: 06/25/2020
• Initial Date FDA Received: 06/25/2020
• Supplement Dates Manufacturer Received: 06/25/2020; 06/29/2020
• Supplement Dates FDA Received: 06/25/2020; 07/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1