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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problem No Patient Involvement (2645)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported complaint for the autopulse platform displayed an error message user advisory (ua) 16 (timeout moving to take-up position) was confirmed during archive review and initial functional testing.The root cause was determined to be a seized brake gap.Brake gap was adjusted to remedy the fault.The platform failed the initial functional testing due to error message user advisory (ua) 16 displayed when the platform was powered on.Review of the archive data indicated user advisory (ua) 16 errors occurred on the reported event date.In addition, unrelated to the reported complaint, archive data log show user advisory (ua) 41 (patient temperature sensor failure) error message.As a precautionary measure, the temperature sensor cabling was replaced.The storage and shift check conditions are not known; however, factors such as ambient storage condition (e.G., fire truck in sun) or soft surface that may block air vents are known to cause (ua) 41 error messages in rare cases.As part of routine service during testing, the platform was examined and unrelated to the reported complaint, encoder drive shaft does not rotate smoothly, exhibits binding and resistance and battery lock was observed damaged.The sticky clutch plate was deburred and the battery lock was replaced.The autopulse platform is a reusable device and was manufactured in february 2016.Therefore, this type of physical damage found during the inspection is characteristic of normal wear and tear for the life of the device.Following the repair, 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 12 minutes without any fault or error.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of reported complaints for autopulse (b)(4).

Event Description

As reported, the autopulse platform ((b)(4)) displayed a user advisory (ua) 16 (timeout moving to take-up position).The user was unable to resolve the issue by resetting the lifeband.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: noemi schambach ; 2000 ringwood ave; san jose, CA 95131 ; 4084192955
• MDR Report Key: 8188046
• MDR Text Key: 131322143
• Report Number: 3010617000-2018-01272
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/20/2018

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: 12/14/2018
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/29/2016
• 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