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

Model Number MODEL 100

Device Problems Sticking (1597); Device Displays Incorrect Message (2591)

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

Event Date 05/03/2015

Event Type  malfunction  

Event Description

It was reported that while using the autopulse platform during patient use and on a mannequin, the device gets stuck in a fixed position and constantly displays a user advisory (ua) 12 (lifeband not present) message.Sometimes the problem is unable to be resolved by replacing the lifeband.Six new lifeband straps have been replaced but the issue still persists.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

Product in complaint was returned to zoll on 05/18/2015 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 evaluation.External inspection of the returned platform was performed no damages were observed.The platform was functionally tested and the reported complaint was unable to be confirmed as the platform displaying a user advisory (ua) 12 (lifeband not present) was not observed.As a precaution the two screws of the lifeband clip reset switch, that hold the lever parallel with the switch case were inspected and verified to be within specification.Using a standard belt clip tool, it was verified that the switch was able to close and the platform does not exhibit a user advisory (ua) 12 fault.Unrelated to the reported complaint it was observed that the encoder shaft was sticky and the clutch plate had sharp edges, which prevented the encoder shaft from being able to spin freely.After, the clutch plate was deburred, the platform ran for 30 minutes, with no user advisories or warnings exhibited.A review of the archive was performed, and no faults or errors occurred on the reported event date of (b)(6) 2015, however ua12 (lifeband not present) was recorded on (b)(6) 2015.Based on the investigation, no parts were replaced to remedy the customer's reported complaint of the platform exhibiting ua12, however the lifeband clip reset switch was inspected and was found to be within specification.In summary, the customer's reported complaint was confirmed.The root cause of the platform displaying a ua 12 could not be determined, however a user advisory 12 is an indication that the autopulse has detected that the lifeband is not properly installed.Unrelated to the reported complaint it was found that the encoder shaft was sticky.The encoder shaft was de-burred, which allowed it to rotate freely without resistance, sticking or binding.The platform passed all final functional 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: 4800022
• MDR Text Key: 19723009
• Report Number: 3010617000-2015-00298
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: IS
• 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
• Report Date: 05/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/27/2015
• 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: 05/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2015
• 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