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

Model Number MODEL 100

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913); Noise, Audible (3273)

Patient Problem No Patient Involvement (2645)

Event Date 01/14/2015

Event Type  malfunction  

Event Description

Complainant alleged that the autopulse® platform intermittently works and displays user advisory (ua) 12 (lifeband not present) and 16 (timeout moving to take-up position) messages.It was also reported that the fan and motor make an unusual sound and the platform will not securely hold lifebands in place.There were no reports of any patient involvement.No further information was provided.

Manufacturer Narrative

Product in complaint was returned to zoll on 01/22/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for analysis.Visual inspection of the returned platform shows that the front cover was cracked and the top cover's wire strands were damaged.The physical damages found during visual inspection are not related to the reported complaint.The damages appear to have been caused by normal wear and tear (autopulse manufactured in 10/2008).A review of the autopulse archive was performed and the archive data shows that no sessions occurred on the reported event date of (b)(6) 2015.The archive does however, show that user advisories (uas) 12 and 16 occurred on (b)(6) 2014.The archive data also shows that user advisory 2 (compression tracking error) faults occurred on (b)(6) 2014.Initial functional testing could not be performed due to the user advisory faults that were exhibited upon power up of the platform.The ua 16 fault observed during functional testing was found to be due to the drive train motor being defective as it was making a loud noise.The lifeband clip was inserted into the encoder shaft and it was observed that it did not lock correctly.The fault was found to be due to the spring washer and the belt clip retainer being worn out.Due to the parts being worn out, the belt clip did not lock properly into the encoder shaft which causes the platform to exhibit a user advisory 12 message.Based on the initial investigation, the parts identified for replacement were the front cover, top cover, drive train motor, spring washer, and the belt clip retainer.In summary, the reported complaint of the ua12 and ua16 faults were confirmed based on review of archive and during functional testing.The reported complaint of the platform being unable to hold the lifeband securely in place was confirmed during functional testing.The report of the fan and motor making and unusual sound were also confirmed during functional testing.The defective drive train motor was replaced to remedy the unusual noises and user advisory 16.The spring washer and the belt clip retainer were replaced to remedy the ua12 fault and the platform being unable to hold the lifeband securely in place.The root cause for ua2 fault could not be determined.Per the autopulse maintenance guide (p/n 11653-001), ua2 is an indication that the patient or lifeband is out of position, or the lifeband is opened during active operation.

• Brand Name: AUTOPULSE® RESUSCITATION SYSTEM 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4509560
• MDR Text Key: 21451290
• Report Number: 3010617000-2015-00084
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: NO
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2015
• 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: 8700-0700-22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/07/2008
• 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