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

Model Number MODEL 100

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Burn(s) (1757); Laceration(s) (1946)

Event Date 01/27/2023

Event Type  Death  

Event Description

The customer reported that the lifeband (lot #unknown) caused skin lacerations on the patient's upper right chest during the resuscitation using the autopulse platform (sn (b)(4)).The customer provided no further information.Please see the following related mfr report: mfr 3010617000-2023-00195 for the lifeband (lot #unknown).

Manufacturer Narrative

Zoll has not received the autopulse platform for investigation.A follow-up report will be submitted when the product is returned, and investigation has been completed.Chest compression, as a part of cardiopulmonary resuscitation (cpr), has a high rate of patient adverse events.Common injuries (skin, rib, sternum and spine fracture), common internal organ injuries (liver and spleen), and common clinical events secondary to those injuries (pneumothorax) are expected adverse event for both manual and mechanical cprs.The chest compression generated by the autopulse system may lead to an injury profile that is no worse than manual cpr.Similarly, a randomized trial of manual cpr and phased manual plus autopulse cpr found no difference in cardiac, pulmonary or cerebral damage.Complications in autopulse-treated patients occurred at a rate not exceeding that of manual cpr.The aha guidelines 2000 states, "even properly performed chest compressions can cause rib fractures in adult patients." the guidelines further state, "concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death." the recently released guidelines 2005 deliver a similar message, "rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest.".The 2015 aha guidelines update for cpr reemphasized the importance of high-quality chest compressions and recommends to ensure adequate compression rates and adequate compression depth.Rib fractures and other injuries are common but acceptable consequences of manual and mechanical cpr.Concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death.In this case, the lifeband (lot #unknown) caused skin lacerations on the patient's upper right chest during the resuscitation using the autopulse platform (sn (b)(4)).The customer provided no further information.Based on available information, the event of skin laceration was not serious since it didn't meet any criteria of seriousness per regulations.Due to the skin laceration location and the time point, the event of skin laceration was probably related to the autopulse device.Query for further details information like patient's weight, size, and concomitant medical condition[?]were sent to customer for clarification.Re-assessment will be made when further information are available.

Manufacturer Narrative

Correction and additional information in section b5 and h6 (clinical code).The reported complaint that the autopulse platform (sn (b)(6) performed three compressions and then it did not work was not confirmed during functional testing.The autopulse platform passed the functional testing without any fault or error and performed as intended.Upon visual inspection, no physical damage was observed on the returned autopulse platform.The review of the archive data revealed a ua4 (battery charge too low), multiple ua 07 (discrepancy between load 1 and load 2 too large) and ua18 (max take-up revolutions exceeded) errors.These user advisory messages are unrelated to the reported complaint.Load cell characterization test was performed and confirmed that both cell modules were functioning within the specification and the ua18 error occurred during no patient or manikin which indicates that these uas were cleared by the user.User advisory is normally a clearable advisory message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.Per the autopulse hangtag - advisory codes description and action, user advisory 4 error message alerts the user that the battery voltage is low.Replaced the battery and press restart.Per the autopulse maintenance guide and autopulse user advisory list, user advisory 07 indicates that the patient/manikin is out of position, or the patient/manikin is not correctly centered.The recommended actions to take for this type of user advisory are: ensure the patient/manikin is aligned correctly (armpits on the yellow line), deploy the shoulder restraint to reduce patient/manikin movement, and press restart to clear the ua.Per the autopulse hangtag - advisory codes description and action, 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 recommended actions to take for this type of user advisory are: pull up completely on the lifeband, ensure that the patient and the band are properly aligned, and press restart.The autopulse platform passed the initial functional test without any fault or error.Zoll awaiting customer's approval for service repair.Msa for the skin burns event: chest compression, as a part of cardiopulmonary resuscitation (cpr), has a high rate of patient adverse events.Common injuries (skin, rib, sternum and spine fracture), common internal organ injuries (liver and spleen), and common clinical events secondary to those injuries (pneumothorax) are expected adverse event for both manual and mechanical cprs.The chest compression generated by the autopulse system may lead to an injury profile that is no worse than manual cpr.Similarly, a randomized trial of manual cpr and phased manual plus autopulse cpr found no difference in cardiac, pulmonary or cerebral damage.Complications in autopulse-treated patients occurred at a rate not exceeding that of manual cpr.The aha guidelines 2000 states, "even properly performed chest compressions can cause rib fractures in adult patients." the guidelines further state, "concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death." the recently released guidelines 2005 deliver a similar message, "rib fractures and other injuries are common but acceptable consequences of cpr given the alternative of death from cardiac arrest." the 2015 aha guidelines update for cpr reemphasized the importance of high-quality chest compressions and recommends to ensure adequate compression rates and adequate compression depth.Rib fractures and other injuries are common but acceptable consequences of manual and mechanical cpr.Concern for injuries that may complicate cpr should not impede prompt and energetic application of cpr.The only alternative to timely initiation of effective cpr for the victim of cardiac arrest is death.Based on available information, the event of skin burns was not serious since it didn't meet any criteria of seriousness per regulations.Due to the skin burns location and the time point, the event of skin burns was probably related to the autopulse device.Query for further details information like patient's weight, size, and concomitant medical condition[?]were sent to customer for clarification.Re-assessment will be made when further information is available.The adverse event of skin burns is probably related to the device and to procedure.Msa for the death event: the death was not related to the autopulse device.The autopulse is used as an adjunct to manual cpr, adjunctive use only indication is prominently displayed on device labels and in the device manual.The benefit of using the autopulse is that it in part substitutes mechanical compressions for the physical labor of manual chest compressions when effective manual cpr is not possible.If the autopulse did not start or unexpectedly stops compressions, rescuer should revert to manual cpr, which is the standard of care.The autopulse is intended to be used as an adjunct to manual cpr on adult patients.In case of stoppage of autopulse the trained user reverts to manual cpr.The transition from autopulse to manual cpr by trained users is similar to the time necessary for rescuer rotation and presents the same workflow as manual cpr.Hence, based on available information, the patients' outcome was not negatively impacted by the interruptions when compared to standard of care manual cpr.Out-of-hospital cardiac arrest (ohca) is one of the main causes of death in industrial nations.About 25% of patients survive this event and make it to the hospital, and even fewer patients survive after 24 hours (nichol, nejm, 2015).In the united states, survival to hospital discharge after non-traumatic emergency medical services-treated cardiac arrest with any first recorded rhythm was 10.6% for patients of any age.Of the bystander-witnessed out-of-hospital cardiac arrests in 2011, 31.4% of victims survived to hospital discharge (mozaffarian, circulation, 2016).Death is an expected outcome for ohca.

Event Description

During device use on a 71-year-old male cardiac arrest patient, the customer reported that the autopulse platform (sn (b)(6) performed three compressions and did not work.Three devices were used during the patient event, autopulse platform, lifeband (lot #unknown), and defibrillator pads, however, it is unknown which device caused the skin burns.Manual cpr was performed for approx.1.5 hours.Patient expired.Customer did not provide information regarding the relationship between the death.However, msa evaluated the incident and it was determined that the death was not related to the autopulse devices.

• 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: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 16461142
• MDR Text Key: 310441992
• Report Number: 3010617000-2023-00194
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000130
• UDI-Public: 00849111000130
• 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,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/19/2023
• 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 Outcome(s): Other
• Patient Age: 71 YR
• Patient Sex: Male