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

Model Number MODEL 100

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2016

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint will not be returned for investigation.Therefore, a physical investigation will not be performed.A supplemental report will be filed if the product is returned and investigation has been completed.The death was not likely related to the use of the autopulse device.The platform was working fine for a while, after it stopped, manual cpr was performed.The autopulse is used as an adjunct to manual cpr in cases of clinical death.If the autopulse did not compress, changing from the autopulse to manual cpr can be made in just a few seconds, and is similar to the time necessary for rescuer rotation.The patients' outcome is not negatively impacted by not using the autopulse and proceeding with standard of care manual cpr.Device not returning.

Event Description

It was reported that during patient use the autopulse platform (s/n (b)(4)) stopped compressions.No error message displayed.The emt responded to an emergency call on (b)(6) 2016.The patient was found in an automobile and was unresponsive.It was unknown how long had been unconscious.The bystander who found the patient, called 911 and started to perform bystander cpr.The police arrived and took over cpr.The emt crew arrived on the scene 3 minutes after the initial call was received.The autopulse platform was prepared and started without issue.The battery indicator noted fully charged and was placed in the autopulse within the previous 24 hour shift.The autopulse performed compressions for 10 minutes and then suddenly stopped.At this point the crew arrived at the hospital and discontinued use of the autopulse, the hospital staff reverted to manual cpr.The patient expired at the hospital.Cause of death is unknown.The crew tested the autopulse when they arrived back at the station.They tested the platform using a manikin without issue.Based on these results, the crew did not send the autopulse into zoll for evaluation.They encountered a similar event during another call on the same autopulse platform.The autopulse displayed a user advisory during this session.This will be addressed in a future mdr that will be filed under mfr: 3010617000-2016-00151 at a later date.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll (b)(4) for investigation.Device history record (dhr) was reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).A visual inspection of the autopulse platform was performed and the front cover was observed to be cracked.The cracked cover is unrelated to the reported complaint.The autopulse platform is a reusable device and was manufactured on july 2010.Therefore, this type of physical damage found during visual inspection is characteristic of normal wear and tear for the life of the device.A review of the archive was performed based on the information reviewed that during the date of the event reported of (b)(6) 16, warning 1 - low battery warning, and user advisory 17 - max motor on time exceeded were noted.The platform was functional tested and the autopulse exhibited no user advisory messages.A run_in testing was performed using the 95% patient test fixture (lrtf) for more than thirty minutes, and did not replicate any of the user advisory or fault.Load cell characterization testing was also performed and confirmed that both load cell modules are functioning within the specification.In summary, the customer's reported complaint was confirmed in the platform's archive data but not during functional testing.Base on the platform's archive on the date of event (b)(6) 2016, the device was used to compress for 10 minutes then stop compression.The battery capacity was exceeded and the low battery was replaced.The device was used to compress with a very large/stiff to compress object/patient.After a 10 minutes of compression, and then stop compression due to user advisory 17 - (max motor on time exceeded) on 2nd battery for low battery.There were no device deficiencies found during evaluation of the returned platform that could have caused or contributed to the reported complaint.It should be noted that autopulse is adjunct to manual cpr.In case of stoppage of autopulse the user reverts to manual cpr.If an autopulse unexpectedly stops compressions, it is not likely to cause or contribute to a patient death or serious injury.

• 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: 5463888
• MDR Text Key: 39203875
• Report Number: 3010617000-2016-00108
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: 04/26/2016

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2016
• Initial Date FDA Received: 02/26/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/18/2014
• 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