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 12/12/2014

Event Type  malfunction  

Event Description

It was initially reported that the driveshaft of the autopulse platform was stuck and would not move.This was observed prior to use.No patient involvement was reported.No further information was provided.The autopulse platform was subsequently returned to zoll for investigation.During investigation, the autopulse platform displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) message.Although the customer did not report this, ua 45 is considered to be a reportable malfunction.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll (b)(4) for analysis.External and internal visual inspection of the returned platform shows no damage.A review of the autopulse archive was performed and the archive data shows that no sessions occurred on the reported event date of (b)(6) 2014.Functional testing was performed and the reported complaint that the driveshaft was stuck and will not move was confirmed.It was observed that the clutch plate was stuck.The clutch plate was cleaned and therefore became unstuck.Additionally a user advisory (ua) 45 (not at "home" position after power-on/restart) fault was observed during servicing of the platform.However, this fault is not related to the reported complaint.Based on the investigation, no parts were identified for replacement.In summary, the reported complaint was confirmed during functional testing.The fault was found to be due to the clutch plate.The root cause for ua45 could not be determined.However, per the autopulse® resuscitation system model 100 user guide (pn: 12555-001), if the driveshaft is not at its home position when the autopulse is powered on, a user advisory (45) will occur.Upon cleaning and freeing the clutch plate, the platform was re-evaluated through functional testing and the platform 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: 4542830
• MDR Text Key: 5516911
• Report Number: 3010617000-2015-00129
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/26/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2014
• 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