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

Model Number MODEL 100

Device Problems Device Inoperable (1663); Battery Problem (2885)

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

Event Date 07/10/2014

Event Type  malfunction  

Event Description

Complainant alleged that the autopulse® platform stops after 10 minutes of use, however, no error messages were displayed.Battery indicates that it is "empty" and no other error messages were observed.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

Zoll circulation has not received the product in complaint.A supplemental report will be filed if and when the product is returned and investigation has been performed.

Manufacturer Narrative

The autopulse platform s/n (b)(4) was returned to the manufacturer for evaluation.Visual inspection of the returned platform was performed and the battery lock was found to be damaged.The returned platform underwent and passed initial functional testing.The system was turned on/off and was run for 30 minutes using an lrtf (large resuscitation test fixture) and no errors were observed.A review of the archive was performed and multiple faults such as warning 1 (low battery warning), ua4 (battery charge state too low) and "time out" errors occurred on (b)(6) 2014, rather than the reported incident date of (b)(6) 2014.Warning 1 is an indication to notify the user that the battery is getting low and will need to be replaced.This warning was exhibited by the platform after li-ion battery (s/n (b)(4)) had been in use for a total of 62 minutes.Of those 62 minutes, the platform was in "active operation" (performing compressions) for more than 51 minutes.The expected run-time for a fully charged li-ion battery is 30 minutes.Per the autopulse® maintenance guide (p/n 11653-001) ua4 occurs when the battery charge becomes low.Li-ion battery s/n (b)(4) ran as expected.The platform exhibited a user advisory (ua) 4, followed by warning 1 as intended when a battery reaches a low power state to prevent interruption in therapy.The customer's reported issue was confirmed as the archive indicated that the platform was in an "idle" state for a 10 minute time frame, causing the platform to "time out" (turn itself off).This is designed into the platform to reduce battery drainage while not in active operation.A review of the archive was performed to assess the customer's battery management practices.Review of the archive shows that the customer is not properly maintaining their batteries because on multiple occasions batteries appear to have been placed in the platform and remained there for multiple days without being charge cycled.The customer is also not performing daily checks of the platform as recommended in the ifu.Based on the investigation, the part identified for replacement was the battery lock.The system underwent and passed all final functional testing.The customer's reported complaint that the platform "stops after 10 minutes" and also displayed an "accu empty" (low battery) message were both confirmed through review of the archive.The platform "timed out" as expected, as the platform was designed to shut down/turn off when in an idle state for 10 minutes.The platform displaying "accu empty" is also an expected message as the battery was in "active operation" performing compressions for more than 51 minutes (the battery was in use on the platform for over 62 minutes total, however not in "active operation" the entire time).As both of these actions are designed into the platform, the platform functioned as intended.

• 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: 3987453
• MDR Text Key: 4885443
• Report Number: 3010617000-2014-00404
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: SZ
• 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,Followup
• Report Date: 07/16/2014

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: 8700-0740-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/22/2014
• Initial Date FDA Received: 08/07/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/29/2014; 10/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/12/2013
• 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