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

Model Number MODEL 100

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/20/2020

Event Type  malfunction  

Manufacturer Narrative

The customer's reported complaint of the autopulse platform stopped compressions after a part of the patient's shirt was pulled into the platform was not confirmed during the functional testing or archive review.There were no device deficiencies found during the evaluation of the returned platform that could have caused or contributed to the reported complaint.The probable root cause for the reported complaint was likely due to the user error.The patient's clothing should be removed from the patient's torso before the use of the platform.Per autopulse platform user guide, section 3.1 deploying the autopulse system: after assessing the patient's condition, sit the patient up and make a single cut down the back of the patient's clothing or undo any ties on the back of the gown in a hospital.Grasp the clothing by the sleeves and pull down toward the ankles to remove all of the clothing from both the front and back of the torso.Ensure that the lifeband is not impeded by anything such as the patient's arms, clothing, straps, and buckles that may interfere with the movement of the lifeband.Visual inspection was performed and noted no clothing/fabric was pulled into the platform preventing movement of the driveshaft as reported by the customer.Also, unrelated to the reported complaint found a cracked front enclosure, likely as a result of damage sustained due to mishandling such as a drop.The cracked front enclosure needs to be replaced to address the issue.In addition, observed the encoder drive shaft does not rotate smoothly, exhibits binding and resistance due to a sticky clutch plate, unrelated to the reported complaint.The sticky clutch plate needs to be deburred to address the issue.The cause for the sticky clutch could be due to normal wear and tear.The autopulse platform is a reusable device and was manufactured in september 2015 and it is nearing the expected serviceable life of 5 years.The autopulse platform failed initial functional testing due to user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message displayed upon powering on, unrelated to the reported complaint.The archive shows the presence of user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message.The load cell characterization test revealed that the load cell1 was over-reporting.The cracked front enclosure and defective load cell were likely attributed to mishandling such as a drop.The defective load cell needs to be replaced to address the user advisory (ua) 07 error.Waiting for customer approval for repair.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with sn (b)(4).

Event Description

Patient #1.Per a reporter, during the patient call, the patient's shirt was tangled with the lifeband and during the compression, a part of the shirt was pulled into the platform preventing movement of the driveshaft.There were no errors noted by the user.Immediately the crew reverted to manual cpr and the patient was successfully transported to the hospital.No consequences or impact to patient.For patient #2 event, see mfr 3010617000-2020-00776.

Manufacturer Narrative

The customer's reported complaint of the autopulse platform stopped compressions after a part of the patient's shirt was pulled into the platform was not confirmed during the functional testing or archive review.There were no device deficiencies found during the evaluation of the returned platform that could have caused or contributed to the reported complaint.Unable to determine if the clutch or the clothing was the root cause for ap stopping compressions.The patient's clothing should be removed from the patient's torso before the use of the platform.Per autopulse platform user guide, section 3.1 deploying the autopulse system: after assessing the patient's condition, sit the patient up and make a single cut down the back of the patient's clothing or undo any ties on the back of the gown in a hospital.Grasp the clothing by the sleeves and pull down toward the ankles to remove all of the clothing from both the front and back of the torso.Ensure that the lifeband is not impeded by anything such as the patient's arms, clothing, straps, and buckles that may interfere with the movement of the lifeband.Visual inspection was performed and noted no clothing/fabric was pulled into the platform preventing movement of the driveshaft as reported by the customer.Also, unrelated to the reported complaint found a cracked front enclosure, likely as a result of damage sustained due to mishandling such as a drop.The cracked front enclosure needs to be replaced to address the issue.In addition, observed the encoder drive shaft does not rotate smoothly, exhibits binding and resistance due to a sticky clutch plate, unrelated to the reported complaint.The sticky clutch plate needs to be deburred to address the issue.The cause for the sticky clutch could be due to normal wear and tear.The autopulse platform is a reusable device and was manufactured in september 2015 and it is nearing the expected serviceable life of 5 years.The autopulse platform failed initial functional testing due to user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message displayed upon powering on, unrelated to the reported complaint.The archive shows the presence of user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message.The load cell characterization test revealed that the load cell1 was over-reporting.The cracked front enclosure and defective load cell were likely attributed to mishandling such as a drop.The defective load cell needs to be replaced to address the user advisory (ua) 07 error.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.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse platform with sn (b)(6).

• Brand Name: AUTOPULSE RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose, ca
• MDR Report Key: 10400548
• MDR Text Key: 203896230
• Report Number: 3010617000-2020-00778
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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,health
• Type of Report: Initial,Followup
• Report Date: 09/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/13/2020
• 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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Date Manufacturer Received: 08/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1