MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® RESUSCITATION 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 04/15/2015

Event Type  malfunction  

Event Description

It was reported that during patient use, the autopulse platform operated for 16 minutes, then stopped and displayed a "reset lifeband" message.The user reset the autopulse lifeband and restarted the platform but the device stopped again.Customer changed the lifeband and battery but the autopulse platform then displayed a "system error, revert to manual cpr" message.Customer again changed to another lifeband and battery but the error message did not resolve.Use of the autopulse was discontinued and the arrest was terminated after 20 minutes.No adverse patient sequelae was reported.No further information was provided.

Event Description

Additional information provided by the customer: the patient expired.However, the customer stated that autopulse platform did not change the patient's outcome in any way.Manufacturer has requested additional information from the customer; however, no additional information has been obtained.

Manufacturer Narrative

Describe event or problem for additional information provided by the customer on (b)(6) 2015.Investigation results for the returned platform as follows: external visual inspection of the returned platform was performed and found that the short black cover was damaged.Internal visual inspection was also performed and no damages were observed.Please note that the results of the visual inspection are unrelated to the reported complaint.A review of the platform's archive data was performed and confirmed the customer's reported complaint of a "system error, out of service, revert to manual cpr" message.The archive data showed that a "system error 139" (unable to hold compression position) message occurred at the end of the session on the reported event date.Consistent with the customer's reported information that about 16 minutes into the arrest, the platform stopped and displayed a "reset lifeband" message, the archive data indicated that multiple user advisory (ua) 17 (max motor on time exceeded during active operation), ua 45 (not at "home" position after power-on/restart) and ua 2 (compression tracking error) messages occurred on the reported event date before the platform displayed the "system error" message.The returned platform displayed a "system error, out of service, revert to manual cpr" message upon power on, thus confirming the reported complaint.Further investigation determined that the processor pca board needed to be reset and cleared in order to clear the "system error" message.Functional testing was continued after the "system error" message was cleared.However, the platform displayed several ua 17 messages during testing.Inspection of the platform found that the cause of the ua 17 messages was a defective drivetrain motor.Unrelated to the reported complaint, it was also observed that the shaft lock pin was worn.Based on the investigation, the parts identified for replacement were the drivetrain motor, the short black cover and the shaft lock pin.In summary, the customer's reported complaint of a "system error, out of service, revert to manual cpr" message was confirmed during review of the platform's archive data and upon functional testing.The root cause was determined to be the processor pca board, which needed to be reset and cleared.Review of the platform's archive data also confirmed that ua 17, ua 45 and ua 2 messages occurred on the reported event date, which is consistent with the customer's reported information that the platform displayed a "reset lifeband" message.The ua 17 was replicated during functional testing of the returned platform.The root cause of the ua 17 was determined to be a defective drivetrain motor.There were no device deficiencies found during investigation which could have caused or contributed to the ua 45 and ua 2 messages.Per review of the archive data, the ua 45 messages occurred because the lifeband straps were not pulled completely up prior to turning the platform on.The ua 2 messages may have occurred if the patient was misaligned on the platform or if the lifeband was opened.Visual inspection found that the short black cover was damaged.It was also observed that the shaft lock pin was worn.These physical damages are unrelated to the reported complaint.After replacement of all the identified parts, the platform was reevaluated through functional testing and passed all final testing criteria.Additional information provided by the customer indicated that the patient expired.However, the customer stated that the autopulse did not change the patient's outcome in any way.Based on the evaluation of the platform, no device deficiencies were identified which could have caused or contributed to the patient's death.

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 05/08/2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

• 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: 4764203
• MDR Text Key: 5789775
• Report Number: 3010617000-2015-00270
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2015

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: 8700-0740
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/26/2015
• Initial Date FDA Received: 05/11/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/25/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2012
• 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