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

Model Number MODEL 100

Device Problems Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/28/2016

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform (s/n: (b)(4)) was returned for evaluation.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of related complaints for autopulse sn (b)(4).No visual damage was noted during visual inspection.During archive review, multiple user advisory (ua) 02 (compression tracking error) was noted on (b)(6) 2016.The platform has passed the initial functional testing without any fault or errors.The platform was tested using lrtf (large resuscitation test fixture, equivalent to 250 pound patient) fixture for approximately 30 minutes and there were no error code noted.A load cell characterization check was performed and both cells are within specification.In summary, the customer reported complaint of the autpulse kept displaying error message "reposition patient" was confirmed during archive review but not during initial functional testing.There were no device deficiencies found during evaluation of the returned platform that could have caused or contributed to the reported complaint.User advisory error messages are designed into the platform when one of several conditions is detected.Ua 02 alerts the user that the patient is not correctly oriented on the autopulse or the patient has shifted or the load cells are damaged.The load cells passed the characterization testing.Therefore, the probable root cause is that either the patient was not placed on the platform evenly or the patient had shifted causing uneven weight distribution on the load cell.The platform passed all final testing.The death was not related to the autopulse device.The autopulse is used as an adjunct procedure to manual cpr in cases of clinical death.The autopulse error message "reposition patient" is a safety feature for the autopulse device.It indicates that the patient is not correctly oriented to the autopusle or the patient has shifted.Failure to properly position the lifeband at the patient's armpit line may cause injury to the patient.If a user advisory or failure cannot be cleared, user shall immediately revert to manual cpr.In this case, the crew performed manual cpr for approximately 20 minutes while transporting the patient to the hospital.The mechanical cpr lucas was used at the hospital for approximately 15 minutes until the patients family requested no further action to be taken.Rosc (return of spontaneous circulation) was not achieved.The cause of patient's death was likely to be cardiac arrest.Mortality of out-of-hospital cardiac arrest (ohca) is high.Death is an expected outcome for ohca.

Event Description

The (b)(6) received a 911 call at 10:20 am on (b)(6) 2016 for a (b)(6) female found unconscious and unresponsive.Upon arrival, the crew deployed the autopulse and error message "reposition patient" was displayed.The customer tried to reset the platform multiple times; however, were unsuccessful.The crew performed manual cpr for approximately 20 minutes while transporting the patient to (b)(6) hospital.Rosc (return of spontaneous circulation) was not achieved.(b)(6) stated that the mechanical cpr device lucas was used at the hospital for approximately 15 minutes until the patients family requested no further action to be taken.No other information was provided.

• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 6214841
• MDR Text Key: 63617694
• Report Number: 3010617000-2016-00955
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000772
• UDI-Public: 00849111000772
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 8700-0730-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2016
• Initial Date FDA Received: 12/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/12/2011
• 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 Age: 90 YR