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 06/16/2020

Event Type  malfunction  

Manufacturer Narrative

The report of the autopulse platform (sn (b)(4)) displayed ua 45 (driveshaft not at "home" position after poweron/restart) error message and the user tried to rotate the drive shaft to home position, however, the drive shaft remain stuck and was unable to be rotated to home position was confirmed during functional testing and archive data review.The root cause for the ua45 error message was due to the driveshaft not being at home position due to the encoder drive shaft was difficult to rotate and exhibited binding and resistance.The clutch plate was deburred and the drive shaft was rotated to home position to clear the ua45 error message.During visual inspection, no physical damage was observed.During archive data review, ua 45 error message was observed.During functional testing, the autopulse platform displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error message" upon powering on.The root cause for the ua45 error message was due to the driveshaft not being at home.After clearing the ua45 error message, the autopulse platform performed compressions without any fault or error using lrtf (large resuscitation test fixture).Historical records were reviewed for service information related to the reported complaint and there was no similar history of complaint reported for autopulse with serial number (b)(4).

Event Description

During shift check, the autopulse platform (sn (b)(4)) displayed user advisory (ua) 45 (not at "home" position after power-on/restart) error message.The user tried to rotate the drive shaft to home position, however, the drive shaft remain stuck and was unable to be rotated to home position.No patient involvement.

• Brand Name: AUTOPULSE PLATFORM RESUSCITATION
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, ca ; 4192922
• MDR Report Key: 10256088
• MDR Text Key: 198783560
• Report Number: 3010617000-2020-00671
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2020
• 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: 06/23/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/29/2016
• 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