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 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform (sn 33106) for investigation.A follow-up report will be submitted when the platform is returned and investigation has been completed.

Event Description

The autopulse platform (sn (b)(4)) displayed fault code 27 (encoder fault) error message after being used on a training manikin.No patient involvement.

Manufacturer Narrative

During service of autopulse platform (sn (b)(4) on (b)(6) 2020, not related to the reported complaint, it was observed that the ir port of the processor board was intermittently transmitting the archive data log file.The root cause was due to the defective processor board due to wear and tear.Unrelated to the reported complaint, noticed broken boss on the top cover and multiple cracked screw well areas on the bottom enclosure.After replacing processor board, encoder gearbox, top cover, front and bottom enclosure, the autopulse platform was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries for 15 minutes without any fault or error.The autopulse platform passed the final testing without any fault or error.

Manufacturer Narrative

The reported event on the autopulse platform (sn 33106) displaying fault code 27 (encoder fault) message was confirmed during functional testing and the archive data review.The root cause was due to a defective encoder gearbox due to wear and tear.The autopulse platform was manufactured on 19 september 2015.It is nearing its service life of 5 years.Unrelated to the reported complaint, cracked front enclosure was observed during visual inspection.Root cause were likely attributed to mishandling such as a drop.During functional testing, the autopulse platform displayed fault code 27 after a few compression.While the spool shaft rotates in either direction (compression), the device monitor changes in the encoder position.A fault code 27 shall be generated if the change in encoder position indicates the shaft turning too fast greater than 3000 rpm.The archive data review showed fault code 27.Waiting for customer's approval for service.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with serial (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: 10198052
• MDR Text Key: 197142976
• Report Number: 3010617000-2020-00637
• 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: 09/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/25/2020
• 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
• Date Manufacturer Received: 08/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1