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 Known Impact Or Consequence To Patient (2692)

Event Date 01/17/2019

Event Type  malfunction  

Manufacturer Narrative

The customer's reported complaint of the autopulse platform displayed user advisory (ua) 18 (max take-up revolutions exceeded) was confirmed during the archived review and during the initial functional testing.The root cause was due to the failed load cells.The customer's reported user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error message was confirmed during the archived review, but not during the initial functional testing.The driveshaft was rotated back to home position prior to the platform evaluation.The likely root cause of the issue was due to user error.User advisory (ua) 45 error message alerts the operator that the autopulse driveshaft is not at its home position when the platform was powered on.This user advisory will persist until the driveshaft is returned to its home position.Per the autopulse user guide instruction, to clear ua 45 error message, the operator needs to pull up the lifeband until the chest bands are fully extended.This action will move the driveshaft to its home position.As part of routine service during testing, the platform was examined and unrelated to the reported complaint, damaged load plate cover was noted.The load plate needs to be replaced to address the issue.During functional testing, user advisory (ua) 18 error message displayed upon powered on the device, thus confirming the reported complaint.Load cell characterization test was performed and both load cells were defective.Review of the archive data indicated user advisory (ua) 18 and user advisory (ua) 45 errors occurred on the reported event date, thus confirming customer complaint.Upon customer approval, the components will be replaced and the device will be further tested to full specification.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints for autopulse platform sn (b)(4).

Event Description

The autopulse platform (sn (b)(4)) was used during a call on (b)(6) male patient and displayed user advisory (ua) 18 (max take-up revolutions exceeded) and user advisory (ua) 45 (driveshaft not at "home" position after power-on/restart) error messages.Troubleshooting steps are unknown.No known impact or patient consequence information was available.

• 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: 8332180
• MDR Text Key: 136153083
• Report Number: 3010617000-2019-00107
• 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,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/12/2019

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?: No
• 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: 01/29/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2019
• Initial Date FDA Received: 02/12/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2017
• 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
• Patient Age: 45 YR