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

Model Number MODEL 100

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Date 05/11/2014

Event Type  malfunction  

Event Description

It was reported that during patient use, the autopulse platform stopped performing compressions and displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) message.Customer readjusted the lifeband and restarted the platform.The platform ran for a few minutes, then stopped and displayed a "system error, out of service" message.Customer immediately reverted to manual cpr (exact length of time was not provided).Customer does not know if return to spontaneous (rosc) was achieved.However, no adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on (b)(6) 2014 for investigation.Investigation results as follows: visual inspection of the returned platform shows that the top cover was cracked and the battery partition cover was missing.The physical damages found during visual inspection are not related to the reported event that the platform displayed a "system error, out of service" message.The damages appear to have been caused by normal wear and tear (autopulse manufactured in june of 2006).A review of the archive was performed and the reported complaint that the platform displayed a "system error, out of service" message was confirmed.The archive data shows that "system error, out of service" (error code 139) and user advisory (ua) 45 (not at "home" position after power-on/restart) messages occurred on the reported event date of (b)(6) 2014.Furthermore, additional ua 7 (discrepancy between load 1 and load 2 too large) and ua 2 (compression tracking error) messages were observed to have occurred on the reported event date.However, the observed ua 45 was cleared by the customer.The observed ua 7 and ua 2 are not related to the reported complaint.In assessing for battery management issues, it was observed that "warning 1 - low battery warning" message and ua 17 (max motor on time exceeded during active operation) occurred on the reported event date with autopulse nimh battery with s/n (b)(4).However, this battery was manufactured in june 2013 and had 16 cycles.Therefore, the battery was properly maintained.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.Functional testing was performed and the reported issue that the platform displayed a "system error, out of service" message (error code 139) was verified.The error code 139 (unable to hold compression position) was cleared.After the error code was cleared, the platform ran with the test mannequin for 10 minutes and no problems were observed.Based on the investigation, the parts identified for replacement are the top cover and the battery partition cover.In summary, the reported complaint that the platform displayed a "system error, out of service" message was confirmed based on the archive review and during functional testing.The error was cleared and the platform passed the functional test.The ua 45 observed in the archive data was cleared by the customer.The ua 7 and ua 2 observed in the archive data are unrelated to the reported complaint.The root cause for these user advisories (ua's) could not be determined.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 and/or the patient is not properly centered.The ua 2 typically occurs if the patient is misaligned on the platform or the lifeband is opened.The physical damages found during visual inspection are unrelated to the reported complaint.The battery management assessment results indicated that proper battery management was performed but this was unrelated to the reported complaint.Upon replacement of the top cover and the battery partition cover, the platform passed all testing criteria.

• 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: 3854814
• MDR Text Key: 16779381
• Report Number: 3003793491-2014-00271
• 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: 05/12/2014

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: 05/29/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/12/2014
• Initial Date FDA Received: 06/06/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/21/2006
• 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