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

Model Number MODEL 100

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

Patient Problems Abrasion (1689); Injury (2348)

Event Date 04/05/2019

Event Type  malfunction  

Manufacturer Narrative

Zoll has not received the autopulse platform (sn (b)(4)) for investigation.A final report will be filed when the product is returned and the investigation has been completed.No device malfunction reported.When responding to a cardiac arrest call, the emergency crew assesses the patient's condition and prepares him or her to be placed on the autopulse platform.The autopulse is applied to the patient as soon as possible after reaching the patient's side.The user positions the patient on the platform, places the lifeband on the patient's chest and powers-up the platform.This is referred to as the deployment state.Once autopulse system chest compressions can be started, the user initiates the active operation state by pressing the start/continue button.At first, the autopulse automatically adjusts the lifeband to the patient's chest.The autopulse will then verify that the patient is properly aligned and the lifeband has taken up any slack in the bands.After three seconds, chest compression will automatically begin.The device provides mechanical cpr continuously throughout the rescue, freeing the emergency team to attend to other aspects of resuscitation such as intubating and defibrillating the patient and establishing iv as needed.The patient may be transported to the emergency department (ed) with continued autopulse chest compression.The patient is then treated per the hospital protocol at the ed.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, "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 autopulse platform was used to resuscitate a male patient within the specified weight limits of the device in the cath lab.The platform performed compressions for about 40 minutes without any issue.However, rosc was not achieved and the patient was pronounced.The user noticed a skin abrasion on the left side of the patient's chest after removing the lifeband.Based on available information, the event of patient's skin abrasions was not serious since it didn't meet any criteria of seriousness per regulations.Due to the skin abrasion location and the time point, the event of skin abrasion was probably related to the autopulse device.

Event Description

The autopulse platform was used to resuscitate a male patient within the specified weight limits of the device in the cath lab.The platform performed compressions for about 40 minutes without any issue.However, rosc was not achieved and the patient was pronounced dead.The user noticed a skin abrasion on the left side of the patient's chest after removing the lifeband.Per user, the outer webbing of the lifeband had moved either prior to application or during use.The lifeband main strap had been rubbing and cut into the patients chest.No further information was provided.The lifeband was discarded, as it got contaminated with body fluids.Please see the following related mfr report: mfr # 3010617000-2019-00344 for the lifeband.

Manufacturer Narrative

There were no device deficiencies found during the evaluation of the returned autopulse platform (sn (b)(4).The autopulse platform performed as intended.Since the lifeband was discarded by the customer, physical investigation of the lifeband could not be performed.Upon visual inspection, no physical damage was observed.The autopulse platform passed the initial functional testing without any fault or error.The archive data review showed no significant discrepancies.Following the service, the autopulse was subjected to the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The brake gap inspection was performed and verified the brake gap was within the specification.Load cell characterization test was performed and confirmed both cell modules are functioning within the specification.Historical complaints were reviewed for service information and there was no previous history of complaint reported for autopulse platform with sn (b)(4).Per autopulse system user guide, failure to properly position the lifeband at the patient's armpit line may cause injury to the patient.Failure to properly position a patient, both vertically and laterally with respect to the autopulse platform, may cause injury to the patient.Do not strap across, or otherwise constrain, the lifeband.Constraining the movement of the bands can damage or break the lifeband.Operating the autopulse on a patient for extended periods of time may result in minor skin irritation to the patient.To avoid these failures, make sure that the yellow upper edge of the lifeband is aligned with the patient's armpits, and is directly over the yellow line on the autopulse platform.Also make sure that there are no obstructions, such as clothing, straps or equipment, with the bands.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, "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 autopulse platform was used to resuscitate a male patient within the specified weight limits of the device in the cath lab.The platform performed compressions for about 40 minutes without any issue.However, rosc was not achieved and the patient was pronounced.The user noticed a skin abrasion on the left side of the patient's chest after removing the lifeband.Based on available information, the event of patient's skin abrasions was not serious since it didn't meet any criteria of seriousness per regulations.Due to the skin abrasion location and the time point, the event of skin abrasion was probably related to the autopulse device.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 8567031
• MDR Text Key: 143668990
• Report Number: 3010617000-2019-00343
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001014
• UDI-Public: 00849111001014
• Combination Product (y/n): N
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/30/2019
• 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: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2019
• Date Manufacturer Received: 05/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other