MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LIFEBAND; CHEST COMPRESSION ASSEMBLY

Model Number 8700-0701-01

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

Patient Problems Abrasion (1689); Injury (2348)

Event Date 04/05/2019

Event Type  Injury  

Manufacturer Narrative

The lifeband was discarded by the user.Therefore the device associated with this complaint will not be returned for evaluation.Since the device was not returned, an investigation could not be performed and a root cause could not be determined.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 # 3010617000-2019-00343 for the autopulse platform.

• Brand Name: AUTOPULSE® LIFEBAND
• Type of Device: CHEST COMPRESSION ASSEMBLY
• 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: 8567030
• MDR Text Key: 143668962
• Report Number: 3010617000-2019-00344
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001571
• UDI-Public: 00849111001571
• 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: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2019

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: 8700-0701-01
• Device Catalogue Number: 8700-0701-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/05/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other