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

Model Number MODEL 100

Device Problems Component Missing (2306); Device Displays Incorrect Message (2591)

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

Event Date 11/17/2014

Event Type  malfunction  

Event Description

Complainant alleged that during a shift check, the autopulse® platform displayed a user advisory (ua) 20 (position out of range) message, that was unable to be cleared.Complainant also reported that the autopulse was missing a head restraint.There was no report of any patient involvement.No further details were provided.

Manufacturer Narrative

Product in complaint was returned to zoll on 11/21/2014 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 was performed which found that both of the head restraint wire strands were damaged and the battery clip was twisted.The platform failed initial functional testing as it exhibited a user advisory 20 (position out of range (no unwind)).A review of the archive was performed and no anomalies were found on the reported event date of (b)(6) 2014, however, multiple ua20s were noted to have occurred on (b)(6) 2014, which is the last recorded customer use of the platform.No parts were replaced to remedy the customer's reported complaint.The platform underwent and passed all final functional testing.The customer's reported complaint of the platform exhibiting a ua20 was confirmed through both review of the archive and initial functional testing (exhibiting the error upon power on).The root cause was determined to be that the encoder shaft was one revolution off from being in the "home" position.The encoder shaft was turned to the "home" position, remedying the customer's reported complaint.

• 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: 4322399
• MDR Text Key: 5256212
• Report Number: 3010617000-2014-00655
• 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: 11/17/2014

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/12/2015
• Initial Date FDA Received: 12/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2007
• 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