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

Model Number MODEL 100

Device Problems Loose or Intermittent Connection (1371); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2016

Event Type  malfunction  

Manufacturer Narrative

Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.H3 other text : device not received for evaluation.

Event Description

It was reported that during patient use the autopulse platform (s/n (b)(4)) lost power and the ems crew had to revert to manual cpr.The crew responded to a call where a 4(b)(6) male who was unresponsive and had no pulse.Manual cpr was immediately initiated by the ems while they prepared the autopulse for use.The autopulse was deployed without issue.The battery showed adequate power.The autopulse performed compressions (length of time is unknown) and they went to move the patient out of the building, then it lost power.The crew reverted to manual cpr during this interval where they changed out the battery and restarted the autopulse.The autopulse performed compressions (length of time is unknown) while the patient was being transported in the ambulance, then it lost power again.The use of the autopulse was aborted and the crew reverted to manual cpr.The patient did not achieve rosc (return of spontaneous circulation).The patient expired before reaching the hospital.The customer does not attribute the death of the patient related to the loss of power of the autopulse.No additional information was provided.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to zoll (b)(4) on 01/28/2016 for evaluation.Investigation is as follows: a dhr review for s/n (b)(4) found no previous complaints related to this event.During visual inspection, the load plate cover was damaged.The archive data review found a "warning 1 - low battery warning" error message.No other problems noted.The platform passed all functional tests without any faults or errors.In summary, the reported loss of power during use was confirmed in the archive data of the autopulse platform.However the platform passed all functional test without any faults or errors.Based on the archive data, it appears that the user pulled the batteries out from the autopulse platform while it was powered on, in an attempt to clear the errors not related to the battery issue (i.E.User advisory (ua) 45 - not at home position, ua 12-life band not present, etc.), this may have contributed to the intermittent loss of power.The power distribution board was replaced, as a pre-caution to reduce the probability of re-occurrence.Performed the run in test (before and after power distribution board was replaced) using the test fixture (lrtf-large resuscitation test fixture) for several hours.User advisory's or faults were not replicated.Device passed final functional test.

Event Description

The call was for (b)(6) male who had chest pain and was found in cardiac arrest.The ems stated there were no signs of trauma to the patient when they arrived on scene.It was witnessed by his (b)(6) son.No bystander cpr was performed.Patient was down for 10 minutes upon arrival of the ems crew.Manual cpr was immediately performed while they prepared the autopulse.Manual cpr was performed for 6 minutes until they started compressions with the autopulse.The auto pulse performed compressions for 15 minutes until is stopped working.The autopulse stopped working when the moved the patient to the ambulance.They started manual cpr until they were inside the ambulance and changed the battery (length of time is unknown).After the battery was replaced they restarted the autopulse, it started without issue.It performed compressions for 20 minutes until it stopped again and manual cpr was restarted.At this time the crew tried to troubleshoot the problem, however they were unsuccessful.Every time the battery was moved slightly, the device powered off.The patient expired.The cause of death is unknown, however the emergency physician's stated that it was possibly related to a pulmonary embolus.The ems stated that the autopulse was checked in the morning of the event.No issue were noted.The autopulse was also checked 3 hours before they received the call.One of the batteries used had been charged for 27 hours prior to this event.The other battery was charged for 3 hours.When the batteries were checked, they both had full power, indicated by their lights as well as on the autopulse display screen.Based on the trouble shooting during the event, the ems thought that the loss of power was from a poor battery contact.

• 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: 5435388
• MDR Text Key: 38228290
• Report Number: 3010617000-2016-00087
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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: 04/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2016
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/07/2004
• 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
• Patient Age: 39 YR