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

Model Number MODEL 100

Device Problems Loss of Power (1475); Device Displays Incorrect Message (2591)

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

Event Date 12/11/2014

Event Type  malfunction  

Event Description

Complainant alleged that during a training session, the autopulse® platform displayed a user advisory (ua) 08 (motor controller fault detected) message and the device was powering down.There was no report of any patient involvement.No further details were 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 (s/n (b)(4)) was returned to zoll (b)(4) for analysis.External and internal visual inspection of the returned platform was performed and no damages were observed.A review of the autopulse archive was performed and the reported complaint that the platform displayed a ua8 (motor controller fault detected) fault was confirmed.The archive data shows that a ua8 fault occurred on the reported event date of (b)(6) 2014.The archive also shows that other user advisories occurred on the same date.These user advisories however, are unrelated to the reported complaint.These user advisories include ua45 (not at "home" position after power-on/restart), ua3 (error communicating with battery controller), ua18 (max take-up revolutions exceeded), ua28 (loss of clutch connectivity), and ua6 (max battery temperature exceeded).Functional testing was performed and the reported complaint of the platform powering down was confirmed.It was observed that the power distribution board was defective.Based on the investigation, the part identified for replacement was the power distribution board.In summary, the reported complaint of ua8 fault was confirmed based on review of the archive but was unable to reproduced during functional testing.The root cause for ua8 fault could not be determined.The reported complaint of the platform powering down, was confirmed during functional testing.The fault was found to be due to the defective power distribution board.The other user advisories observed in the archive review are unrelated to the reported complaint.The root cause for these user advisories could not be determined.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.Per the autopulse maintenance guide (p/n 11653-001), ua3 is an indication that the battery may be loose or not fully inserted.For ua18, the autopulse has detected that there is no patient on the platform.Upon replacement of the power distribution board, 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: 4376339
• MDR Text Key: 5238421
• Report Number: 3010617000-2014-00686
• 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,Health Professional
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 12/11/2014

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: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/05/2015
• Initial Date FDA Received: 12/31/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2012
• 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