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

Model Number MODEL 100

Device Problem Device Alarm System (1012)

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

Event Date 03/23/2015

Event Type  malfunction  

Event Description

It was reported that during a shift check, the autopulse platform displayed a user advisory (ua) 41 (patient temperature sensor failure) message upon power up.The customer was unable to clear the fault.There was no report of any patient involvement.No further details were provided.

Manufacturer Narrative

The autopulse platform (s/n (b)(6)) was returned to the manufacturer for evaluation.Visual inspection was performed and no damages were observed.The platform displayed a user advisory 41 (defective patient temperature sensor) upon power up, thus confirming the reported complaint.No further functional testing could be performed due to the ua 41.Further inspection determined that the patient temperature sensor cable was improperly seated onto the power distribution board thus causing the ua 41 to be displayed.After re-seating the cable into the correct position, the platform was functionally tested for 15 minutes using a large resuscitation test fixture (lrtf) and an additional 10 minutes using a test mannequin and no further user advisories or warnings observed.A review of the archive was performed and no user advisory codes were observed on the reported event date of (b)(6) 2015.However multiple ua 41 codes were seen on (b)(6) 2015.Based on the investigation, there were no parts identified for replacement.In summary, the reported complaint was confirmed during functional evaluation as well as archive review and is attributed to the patient temperature sensor cable not being properly seated onto the power distribution board.Following service, including properly re-seating the cable onto the pdb, the device passed all testing criteria.

• 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: 4704574
• MDR Text Key: 5720254
• Report Number: 3010617000-2015-00236
• 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
• Report Date: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2015
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2013
• 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