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); Failure to Power Up (1476); Device Displays Incorrect Message (2591)

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

Event Date 06/19/2014

Event Type  malfunction  

Event Description

Complainant alleged that the autopulse® platform displayed a user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) message upon power up.The fault was unable to be cleared after being used on a patient, therefore the crew reverted to manual cpr (exact length of time is unknown).Information regarding outcome of the patient is unknown, however no adverse patient sequelae was reported.No further information was 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

The autopulse platform (s/n (b)(4)) was returned for evaluation.Visual inspection identified that the top cover was cracked near the on/off button and the battery lock pin was bent.From the condition of the returned platform, the damages appear to be normal wear and tear.During functional testing, the platform exhibited user advisory 7 (discrepancy between load 1 and load 2 too large) faults consistently.Further inspection found that the cause was a single point load cell that was not functioning properly.The load cell was replaced to remedy the complaint.Unrelated to the reported complaint, the platform's driveshaft was also found to be difficult to rotate.Further inspection identified the cause to be that the clutch plate was damaged.The clutch plate was replaced and the compartment was cleaned to remedy this issue.Review of the archive data confirmed that user advisory (ua) 7 fault had occurred on multiple dates, including the reported event date of (b)(6) 2014.Based on the investigation, the parts identified for replacement were the single point load cell, top cover, battery lock pin, load plate cover, and clutch plate.In summary, the reported complaint of a ua 7 fault occurring was confirmed based on functional evaluation as well as through archive review.The ua 7 fault was found to be due to a single point load cell that was not functioning properly.During functional testing, the driveshaft was also found to be difficult to rotate, which was caused by the clutch plate being damaged.Following service, including replacement of the damaged parts, the device passed all testing criteria.

• 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: 3933374
• MDR Text Key: 4577357
• Report Number: 3003793491-2014-00339
• 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: 06/19/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2014
• 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: 07/11/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/14/2014
• 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
• Treatment: MANUAL CPR