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

Model Number MODEL 100

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 10/24/2014

Event Type  malfunction  

Event Description

It was reported that during an inspection, the fan of the autopulse platform did not run when the platform was turned on.The platform then displayed a fault code 8 (motor controller fault detected) when the "restart" button was pressed.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 04/24/2015 for investigation.Investigation results as follows: visual inspection of the returned platform was performed and found that the front enclosure was cracked.The physical damage found during visual inspection is unrelated to the customer's reported complaints.The customer's reported complaint that the fan did not run when the platform was powered on was not duplicated or confirmed during functional testing.The fan ran for a few seconds when the platform was powered on.The customer's reported complaint of a fault 8 (motor controller fault detected) message was duplicated and confirmed during initial functional testing.Further investigation found a defective motor controller.Unrelated to the reported complaints, it was observed that the lifeband was falling off.Further investigation found that the cause of this issue was the channel roller assembly.A review of the platform's archive data was performed and confirmed that multiple fault 8 codes occurred on (b)(6) 2014, rather than on the reported event date of (b)(6) 2014.Unrelated to the reported complaints, the following user advisory (ua) messages also occurred on (b)(6) 2014: ua 2 (compression tracking error), ua 12 (lifeband not present), ua 23 (compression will exceed 3 revolutions) and ua 45 (not at "home" position after power-on/restart).Based on the investigation, the parts identified for replacement were the motor controller, the channel roller assembly and the front enclosure.In summary, the customer's reported complaint of the platform displaying a fault 8 message was confirmed through review of the platform's archive data and during initial functional testing.The root cause was determined to be a defective motor controller.The customer's reported complaint that the fan did not run when the platform was turned on was not confirmed or duplicated during testing.There were no device deficiencies found during evaluation which could have caused or contributed to the customer's report that the fan did not run.Therefore, a root cause could not be determined.Unrelated to the reported complaints, the archive data indicated that ua 2, ua 12, ua 23 and ua 45 messages occurred on the same day as the fault 8 messages.Per the autopulse® maintenance guide (p/n 11653-001), ua 2 is an indication that the autopulse® has detected a change in lifeband® tension.This advisory can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation.Please note that the customer reported that there was no patient involvement and did not indicate if a mannequin was used in the reported event.Per the autopulse technical service guide (p/n 11377-006), ua 23 may occur when the lifeband straps are not pulled completely out of the channel.Per the autopulse resuscitation system model 100 user guide (pn: 12555-001), "the autopulse driveshaft has a "home" position that is a point of reference for autopulse operation.If the driveshaft is not at its home position when the autopulse is powered on, a user advisory (45) will occur.This user advisory will persist until the driveshaft is returned to its home position.To clear a user advisory (45), pull up on the lifeband until the chest bands are fully extended (thereby moving the driveshaft back to its home position), and then press restart." it should also be noted that per the "warning" indicated in the autopulse user guide, "removing the band clip when the driveshaft is not at its home position will result in a permanent user advisory (45) that the user will not be able to clear.This may be the case if the lifeband has been cut." based on evaluation of the platform, there were no device deficiencies found which could have caused or contributed to the ua 2, ua 23 and ua 45 messages.Therefore, a root cause for these ua's could not be determined.During functional testing of the returned platform, it was observed that the lifeband was falling off, which could have led to the ua 12 message observed in the platform's archive.Per the autopulse® maintenance guide (p/n 11653-001), ua 12 is an indication that the autopulse has detected that the lifeband is not properly installed.Further investigation determined the root cause to be the channel roller assembly.The lifeband issue found during functional testing and the ua 12 found during review of the platform's archive are unrelated to the reported complaints.The physical damage found during visual inspection is also unrelated to the customer's reported complaints.After replacement of the parts identified during investigation, the platform passed all final functional testing criteria.

• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4260073
• MDR Text Key: 16854203
• Report Number: 3010617000-2014-00612
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/24/2014

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: Service and Testing Personnel
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2015
• Initial Date FDA Received: 11/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2012
• 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