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 07/20/2014

Event Type  malfunction  

Event Description

It was reported that on (b)(6) 2014, the autopulse platform was used on a male patient who was (b)(6) and weighed (b)(6) pounds.Patient was transported to the er in 35 minutes.After arrival at the er, the crew changed the battery out and continued use of the autopulse.The platform performed 2 or 3 compressions, then stopped and displayed a "realign patient" message.The crew realigned the patient and restarted the platform.Again, the platform performed 2 or 3 compressions, stopped and displayed the same "realign patient" message.Customer stated that compressions with the platform were slow and lethargic.One emt described it as though the autopulse had become tired.This happened several times.Customer indicated that the patient was strapped onto the platform and that the platform was zip-tied to the backboard.The crew eventually removed the lifeband and reverted to manual compressions (exact length of time was not provided).No adverse patient sequelae was reported.No further information was provided.

Manufacturer Narrative

Customer stated that after the call, a mannequin was placed on the autopulse and it worked fine.The autopulse platform in complaint was returned to zoll on 08/07/2014 for investigation.Investigation results as follows: visual inspection of the returned platform shows no visual or physical damages to the platform.A review of the autopulse archive was performed and the reported complaint that the autopulse platform performed 2 or 3 compressions, stopped and displayed a "realign patient" message was confirmed.The archive data shows that user advisory (ua) 2 (compression tracking error) fault occurred on the reported event date of (b)(6) 2014.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.The archive also shows that ua 12 (lifeband not present) and ua 17 (max motor on time exceeded during active operation) faults occurred on the reported event date.In addition, the archive data analysis shows that the platform ran for 34 minutes before stopping.Afterwards, the platform produced 2-3 compressions and then stopped.Battery management assessment was performed and the archive data shows that a warning 1 (low battery warning) message occurred after the platform ran for 41 minutes with a li-ion battery (s/n (b)(4)).Battery s/n (b)(4) was manufactured in april of 2014 and had been properly maintained.Furthermore, an investigation conducted using the battery's serial number found that the battery was within 2 years of the expected service life.Functional testing was performed with known good batteries and the reported issue could not be reproduced.The platform ran for 30 minutes with a test mannequin and another 30 minutes with a large resuscitation test fixture (lrtf) with no faults observed.Based on the investigation, no parts were identified for replacement.In summary, the reported complaint was confirmed based on the archive review but could not be reproduced during functional testing.Ua 2, ua 12 and ua 17 faults were observed in the archive review.Ua 2 and ua 12 are related to the reported event.Ua12 is an indication that the autopulse has detected that the lifeband is not properly installed and ua 2 indicates that the patient or the lifeband is out of position.Ua 17 is an indication that the lifeband is twisted or that the battery voltage is low.The compression time for a li-ion battery is 30 minutes.In this event, the platform was in active operation for 41 minutes.If the battery voltage is low, then the platform will exhibit a ua 17 message.The autopulse platform performed as intended for 41 minutes.The platform was evaluated through functional testing and passed all testing criteria.No replacement parts or servicing was required for the platform.

• 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: 4025903
• MDR Text Key: 4801801
• Report Number: 3010617000-2014-00420
• 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: 07/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2014
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/12/2014
• 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
• Patient Weight: 100