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

Model Number MODEL 100

Device Problems Device Stops Intermittently (1599); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2018

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform stopped compressions after 2-3 minutes and system error, out of service, revert to manual cpr displayed was not confirmed during functional testing.The second customer complaint for the platform displayed user advisory (ua) 45 (not at "home" position after power-on/restart) upon powering on the platform was also not confirmed during functional testing.The autopulse underwent functional testing with a large mannequin fixture (equivalent to 250 pounds patient) for 19 minutes and for 5 minutes using test manikin.The platform passed functional testing with no fault.There were no device deficiencies found during evaluation of the platform which could have caused or contributed to user advisory (ua) 17 (max motor on time exceeded) and user advisory (ua) 45 error message.In addition, during the evaluation, user advisory (ua) 12 (lifeband not present) was observed intermittently and the sticky clutch plate was noted, unrelated to the reported complaint.Switch belt assembly was adjusted and clutch plate was deburred to remedy the issue.The autopulse passed all the testing and met all required specifications.A review of the autopulse's archive was performed and it shows user advisory (ua) 17 and user advisory (ua) 45 occurred on the event date, thus confirming the reported complaint.The archive also shows user advisory (ua) 12 to have occurred on the event date but it's unrelated to the reported complaint.The platform stopped performing compression due to user advisory (ua) 17.The root cause was due to the platform not reaching the target depth within specification due to the stiff patient.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.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.User advisory (ua) 12 is an indication that the autopulse has detected that the lifeband is not properly installed.The most likely cause of the platform exhibiting ua12 was determined to have been movement of the patient & platform, causing the lifeband to become detached from the platform.Historical complaints were reviewed for service information related to the reported complaint and there was one similar complaint for autopulse sn (b)(4), reported under ccr (b)(4).The complaint was reported on (b)(6) 2017.The platform stopped performing compression due to user advisory (ua) 17 (max motor on time exceeded).The root cause was due to the platform not reaching the target depth within specification due to the stiff patient and the low voltage battery used during the event.

Event Description

During patient use, customer reported that the autopulse platform stopped compressions after 2-3 minutes of operation and displayed "system error, out of service, revert to manual cpr".The crew immediately switched to manual cpr.There was no report of patient consequence as a result of the reported issue.Following the event, the platform was powered on and displayed user advisory (ua) 45 (not at "home" position after power -on/restart).The customer reported 2 separate events involving same platform.This complaint is for the first event occurred during the patient use.For the second event see mfr: 3010617000-2018-00501.

• 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: 7481660
• MDR Text Key: 107331914
• Report Number: 3010617000-2018-00500
• 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: Health Professional
• Type of Report: Initial
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/02/2018
• 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: 04/11/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2016
• 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