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

Model Number MODEL 100

Device Problems Device Alarm System (1012); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 06/11/2014

Event Type  malfunction  

Event Description

Complainant alleged that upon inspection after a transport, the autopulse® platform displayed a user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) message, that was unable to be cleared by powering the device on/off.There was no report of any patient involvement.No further details were provided.

Manufacturer Narrative

Product in complaint was returned to zoll circulation on (b)(4) 2014 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Manufacturer Narrative

Autopulse platform s/n (b)(4) was returned to zoll medical for evaluation.Visual inspection of the returned platform was performed and found that the front enclosure was cracked.From the condition of the platform, the damage appeared to be attributed to wear and tear.Initial functional testing of the platform was unable to be performed as the platform exhibited a ua 7 (discrepancy between load 1 and load 2 too large) message upon power up.A root cause of the ua7 errors was determined to be that both load cells were not functioning properly.While undergoing additional functional testing and upon replacement of the load cells, the platform exhibited a ua 17 (max motor on time exceeded during active operation) and ua 27 (encoder fault (> 3000 rpm)) message.It was determined that the processor board was the root cause of both of these errors.Unrelated to the observed faults, it was also found that the encoder gearbox was loose during compressions.Both the processor pca assembly and encoder gearbox were replaced.A review of the archive was performed and multiple ua 7, ua17, ua 45 (not at "home" position after power-on/restart) errors occurred on the reported incident date of (b)(6) 2014.A root cause of the ua45 errors was unable to be attributed to any specific component, therefore the root cause of the error is likely attributed to the lifeband not being properly pulled up prior to use (user error).The load cells were replaced, which remedied the customer's reported complaint of the platform exhibiting a ua 7.Additional parts replaced not related to the reported complaint to ensure that the autopulse platform is functioning without issue: power distribution board (pdb), processor pca assembly, integrated encoder gear box, and grip strip set.The platform underwent and met all final testing criteria.The customer's reported complaint that the platform exhibited a ua7 was confirmed through both functional testing and review of the platform archive.The root cause of the ua7 was determined to be both load cells not functioning properly.The load cells were replaced, remedying the ua7 error.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION, INC; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 3917557
• MDR Text Key: 4584464
• Report Number: 3003793491-2014-00325
• Device Sequence Number: 1
• Product Code: DRM
• 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: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2014
• 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: 06/26/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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