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

Model Number MODEL 100

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/19/2015

Event Type  malfunction  

Event Description

It was reported that during patient use on a cardiac arrest resuscitation, the autopulse li-ion battery had to be held manually in the battery compartment of the autopulse platform in order for the platform to function.Customer reported that the tab inside the battery compartment of the platform and part of the case were broken.No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 04/13/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Manufacturer Narrative

Investigation results for the returned platform as follows: visual inspection of the returned platform was performed and found that the top cover and both patient head restraint brackets were cracked, the battery bay compartment was broken and the battery partition cover was missing.The customer's reported complaint that the tab inside the battery compartment was broken was confirmed during visual inspection.The customer's reported complaint that the battery had to be held manually in the battery compartment of the autopulse platform in order for the platform to function was confirmed upon functional testing.The platform was unable to undergo initial functional testing because of the broken battery bay compartment, which prevented the battery from locking and latching into the bay.A review of the platform's archive data was performed and found the following user advisory (ua) messages on the reported event date of (b)(6) 2015: ua 3 (error communicating with battery controller), ua 27 (encoder fault (speed > 3000 rpm, no unwind)), multiple ua 45 (not at "home" position after power-on/restart) and multiple battery lost messages.The ua 27 and ua 45 messages are unrelated to the reported complaints.Per the autopulse® maintenance guide (p/n 11653-001), ua 3 occurs when the battery is loose or not fully inserted and ua 27 is exhibited when the lifeband is pulled up too rapidly.Ua 45 is most commonly exhibited when the lifeband straps are not fully extended before pressing start.The battery lost messages recorded in the archive occurs when the battery is removed from the platform before it has been powered off.In this case, because the battery bay compartment was broken, it is most likely that the battery became loose and lost its connection.Based on the investigation, the parts identified for replacement were the battery bay compartment, the top cover including both head restraint brackets and the battery partition cover.The platform then underwent and passed all final functional testing.In summary, the customer's reported complaints that the battery had to be held manually in the battery compartment and that the tab inside the battery compartment was broken were confirmed through both visual inspection and upon functional testing of the platform.The platform was unable to undergo initial functional testing because of the broken battery bay compartment.The root cause of the broken battery bay compartment was determined to be normal wear and tear due to the age of the platform.Review of the platform's archive data also found ua 3 and battery lost messages on the reported event date.These messages confirm the customer's reported event.The battery lost messages recorded in the archive occurs when the battery is removed from the platform before it has been powered off.In this case, because the battery bay compartment was broken, it is most likely that the battery became loose and lost its connection, leading to the observed ua 3 message.The ua 27 and ua 45 messages are unrelated to the reported complaints.After replacement of all the damaged parts, the platform was functionally evaluated and passed all final functional testing.

• Brand Name: AUTOPULSE® RESUSCITATION 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: 4729006
• MDR Text Key: 5581633
• Report Number: 3010617000-2015-00254
• 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,Followup
• Report Date: 04/03/2015

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: 04/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2015
• Initial Date FDA Received: 04/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/10/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2004
• 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