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

Model Number MODEL 100

Device Problem Device Displays Incorrect Message (2591)

Patient Problems Death (1802); Bone Fracture(s) (1870); Rupture (2208)

Event Date 06/01/2014

Event Type  Injury  

Event Description

The initial call was for an unresponsive (b)(6) year old female patient.The arrest occurred at the patient's residence and was witnessed by the patient's husband.However, patient's husband did not know it was an arrest.It is unknown how long the patient was down for prior to ems arrival.Manual cpr was performed by the first ems responder (exact length of time was not provided).The autopulse platform was deployed after a few minutes with no issues.The platform performed compressions for 40 minutes and then displayed a "replace battery" message.The autopulse li-ion battery was immediately replaced with another one when the platform was paused for ventilation.There were no other error messages displayed on the autopulse platform.Head immobilizer and shoulder restraints were not used.Patient was transported to the hospital in 15 minutes.It is unknown what was done during transport or if any medications were administered.Upon arrival at the hospital, a clinician initiated manual cpr for an unknown length of time.While ems crew prepared the autopulse for deployment again, the clinician's husband took over manual compressions for a maximum of 2 minutes.The platform was then deployed and performed compressions for about an hour until resuscitation efforts were discontinued.Manual cpr was not performed after use of the autopulse.Return of spontaneous circulation (rosc) was never achieved.Patient was pronounced dead on (b)(6) 2014 by a doctor.The cause of death was due to embolism.It was reported that the hospital identified multiple rib and liver ruptures.It is unknown if the rib and liver injuries were caused by the autopulse.However, ems stated that the autopulse was not faulty at all and that the patient was positioned correctly.Both the ems service and the hospital are unwilling to provide any patient information.Therefore, patient medical history and preexisting conditions are not available.An autopsy was performed; however, the ems service and hospital indicated that the report is not available due to privacy reasons.No further information was provided.

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.

Manufacturer Narrative

Please see section b.Box 5.Describe event or problem for additional information provided by the customer.Manufacturer received additional clarification, which indicated that manual cpr was performed by the "clinician", who was the ems responder.In addition, the patient's husband performed manual cpr after the "clinician", not the "clinician's husband".The initial report also indicated that manual cpr was performed at the hospital.However, further clarification indicated that the autopulse platform was the only form of cpr used at the hospital.The first battery was changed at the hospital during a pause for rhythm check, not for ventilation.The second battery performed compressions for 20 minutes before resuscitation efforts were discontinued, not for an hour.The autopulse platform involved in the reported event was returned to zoll on 07/31/2014 for investigation.Investigation results are as follows: visual inspection of the returned platform shows no damages to the platform.A review of the autopulse archive was performed.The archive data confirmed that clinical use with a patient occurred.The archive also shows that a user advisory (ua) 18 (max take-up revolutions exceeded) fault occurred during the patient event.Battery management assessment was performed and it was observed that li-ion batteries with s/n (b)(4) were used during the event.Archive analysis shows that a warning 1 (low battery warning) message and a ua 4 (battery charge state too low) message occurred with li-ion battery with s/n (b)(4).The archive data shows that this battery ran for 41 minutes before the error messages were exhibited.The archive also shows that li-ion battery with s/n (b)(4) ran for 13 minutes without any issues.Both of the li-ion batteries were properly maintained.The expected time for use for a battery is 30 minutes.Li-ion battery with s/n (b)(4) ran for 41 minutes which within the battery functioning parameters.Warning 1 and ua 4 messages would be exhibited if the battery is used for more than 30 minutes.Note that warning 1 and ua 4 codes are designed into the device to prevent patient harm.These codes inform the user that the battery's charge is too low and should be replaced with a new, fully charged battery.Functional testing was performed and the platform passed the initial system test.A load cell characterization was performed and indicated that both of the load cells were functioning as intended.The platform ran with a 95% test fixture with known good batteries for several hours.No faults or errors were observed.Based on the investigation, no parts were identified for replacement.In summary, the reported patient event was confirmed based on the archive review.The root cause for the ua 18 could not be determined.However, user advisory 18 is an indication that the autopulse® has detected that either the patient's chest is too small while sizing the patient (take-up) or that there is no patient on the platform.The battery management assessment confirmed that both of the li-ion batteries performed as intended.The root cause for the ua 4 fault is related to the use of the li-ion battery beyond its expected time of 30 minutes.The warning 1 message is also related to the battery being used beyond the expected time of 30 mins.The platform was evaluated through functional testing and passed all testing criteria.The autopulse run time requirement is for a minimum of 30 minutes.The autopulse successfully performed compressions for 41 minutes with the first battery and 13 minutes with the second battery before resuscitation efforts were discontinued.There was no device malfunction reported and the platform worked as intended.Return of spontaneous circulation (rosc) was never achieved with successful mechanical or manual compressions.Additionally, the customer reported that the cause of death was due to embolism.Patient's death was not attributable to the autopulse.It was reported that the hospital identified multiple rib and liver ruptures.It is unknown if the rib and liver injuries were caused by the autopulse.However, ems stated that the autopulse was not faulty and that the patient was positioned correctly during active operation of the platform.Liver and rib ruptures are injuries that are known to possibly result from manual cpr as well as mechanical cpr.Since both manual and mechanical cpr were performed, it is not possible to identify which of the two cpr methods may have caused the suspected injuries.The information reported does not establish a causal relationship of the reported injuries to the autopulse platform.Data from 12 different published reports indicates that the rate of liver injuries from manual cpr is 2.40% and the rate of rib fractures from manual cpr is 33%.

Event Description

Additional information provided by the customer: manual cpr was performed by the first ems responder for about 2 minutes and then by the patient's husband for another 2 minutes.

• 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: 3951350
• MDR Text Key: 4610851
• Report Number: 3003793491-2014-00345
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/13/2007
• 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; CHEST COMPRESSION ASSEMBLY, AUTOPULSE LIFEBAND
• Patient Outcome(s): Other