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

Model Number MODEL 100

Device Problem Device Alarm System (1012)

Patient Problem No Patient Involvement (2645)

Event Date 07/09/2014

Event Type  malfunction  

Event Description

It was reported that during a training by the customer's staff, the autopulse platform stopped performing compressions and displayed a user advisory (ua) 8 (motor controller fault detected) message.The platform was power-cycled and the battery was changed but the message did not clear.No patient involvement was reported.No further information was provided.Please note that the date of event is unknown.Manufacturer has requested additional information from the customer; however, no additional information has been obtained.

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 08/19/2014 for investigation.Investigation results as follows: visual inspection of the returned platform shows no damages to the platform.A review of the autopulse platform's archive was performed and the reported complaint of a fault 8 (motor controller fault detected) was confirmed.The archive data shows that multiple user advisory (ua) 8 faults occurred on the reported event date of (b)(6) 2014.Functional testing was performed and the reported issue of a ua 8 fault was verified.It was found that the bushing inside of the motor had slipped, which caused the drive train to be non-functional.Based on the initial investigation, the part identified for replacement was the drive train.In summary, the reported complaint of a ua 8 fault was confirmed based on the archive review and during functional testing.The fault was found to be due to the defective drive train.

Manufacturer Narrative

Further investigation was performed by zoll and indicated that the motor controller board was replaced to address the reported user advisory (ua) 8 (motor controller fault detected) fault.Based on the investigation, the parts identified for replacement were the drive train motor, the clutch plate and the motor controller board.In summary, the reported complaint of a ua 8 fault was found to be due to the defective motor controller board and the drive train motor.Upon replacement of all parts, the platform was re-evaluated through functional testing and 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: 4043005
• MDR Text Key: 4902194
• Report Number: 3010617000-2014-00432
• 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,Health Professional,Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2014
• 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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/23/2011
• 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