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

Model Number MODEL 100

Device Problems Failure to Align (2522); Device Displays Incorrect Message (2591)

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

Event Date 06/10/2014

Event Type  malfunction  

Event Description

Complainant alleged that during patient use, the autopulse® platform was experiencing alignment issues.The exact error code was not recorded.The patient was re-positioned, however the "alignment error" continued to persist and the device was unable to deliver therapy.Customer reverted to manual cpr (exact length of time was not provided).Customer was unable to provide any patient information and is unaware of any adverse effects to the patient.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to manufacturer for analysis.Visual inspection of the returned platform shows no visible damage.A review of the archive was performed and the reported complaint of "alignment error" was confirmed.The archive data shows that user advisories 7 (discrepancy between load 1 and load 2 too large) and 2 (compression tracking error) occurred on (b)(4) 2014 rather than on the reported event date of (b)(4) 2014.A user advisory 17 (max motor on time exceeded during active operation) was also observed on the (b)(4) 2014, however, this is unrelated to the reported complaint.Functional testing was performed and the reported issue of "alignment error" could not be reproduced.The platform was run for 5 minutes with a test manikin using the customer's lifeband and no problems were found.In addition, the platform was also ran for 5 minutes with the lrtf (large resuscitation test fixture) which is equivalent to 250 pounds and no problems were observed.In summary, the reported complaint of "alignment error" occurring was confirmed based on the archive review but could not be reproduced during functional testing.The root cause for ua7, ua17 and ua2 could not be determined.However, per the battery hangtag - advisory codes description and action (pn 12741-001), user advisory 7 is an indication that the patient is out of position, the patient is not properly centered.Per the battery hangtag - advisory codes description and action (pn 12741-001), user advisory 17 is an indication that the lifeband is twisted or battery voltage is low.Per the battery hangtag - advisory codes description and action (pn 12741-001), user advisory 2 is an indication that the autopulse® has detected a change in lifeband tension.This advisory can happen when the patient or lifeband is out of position, or if the lifeband is opened during active operation.

• 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: 3913521
• MDR Text Key: 20018255
• Report Number: 3003793491-2014-00322
• 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: Biomedical Engineer
• Type of Report: Initial
• Report Date: 06/11/2014

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/11/2014
• Initial Date FDA Received: 07/03/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/25/2006
• 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
• Treatment: MANUAL CPR