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

Model Number MODEL 100

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913); Device Operational Issue (2914)

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

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform was returned to zoll on 19 july 2017 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

As reported, three (3) autopulse platforms stopped compression after 10 minutes of use.During a follow-up call with the reporter, it was mentioned that 4 separate events occurred while using one of the platforms.However, it is not known which of the three platforms were used at the time of event.The patient care report (pcr) involving the platforms was requested.Per patient care report (pcr), ems responded to a call of a (b)(6) male (b)(6) patient in respiratory distress.While en route, it was noted the patient had stopped breathing completely.Upon arriving on the scene, the patient was found slumped in the car seat in full cardiac arrest.The patient was transferred to a backboard and manual cpr by ems was immediately performed.After two minutes of manual cpr, vitals were check, and defibrillation at 200 joules was given; however, there was no change in response.After approximately 8 minutes of manual cpr was provided (stopping every two minutes to recheck vitals and to change rescuers) the autopulse platform was placed and ems was en route to the hospital.During transit, the emt paused the autopulse every two minutes to monitor rhythm checks.Patient remained asystole.Upon arriving at the hospital, at an unspecified time later, it was reported that the platform stopped compression.There were no reports of an error message displayed.The lifeband was removed and manual cpr (by emt) continued into the er until the er team and the er physician took transfer of care of the patient.According to the pcr, approximately 20 minutes after transfer of care, time of death was called by the er physician.Per documentation, the cardiac arrest was triggered by a hypoxic breathing problem.No further information was provided.This is 2 of 4 complaint.Mfr 3010617000-2017-00599 = (b)(4).Mfr 3010617000-2017-00628 = (b)(4).Mfr 3010617000-2017-00640 = (b)(4).

Manufacturer Narrative

Visual inspection was performed and noted no physical damage.Based on the archive file data, the platform was not used on any of the reported event dates nor were there any significant discrepancies or issues that correlated with the reported complaint.The autopulse platform passed functional testing without any issues.This testing was performed with a large rtf using the returned batteries (s/n's (b)(4)) until fully discharged without any faults or errors.The run time on all batteries during this test ranged from 39 minutes to 50 minutes, which is within normal expected operating range.Similar to the previous autopulse platform, additional maintenance and inspections were completed (unrelated to the reported complaint) to ensure that the autopulse platform will continue to function properly, including deburring the clutch plate, load cell characterization and brake gap inspection.After all work was completed, the autopulse platform was assessed again to ensure it met all specifications and passed all functional testing.There was nothing found during evaluation of autopulse s/n (b)(4) which could have caused or contributed to the reported complaint.The autopulse functioned as intended.

• 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: noemi schambach ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192955
• MDR Report Key: 6772372
• MDR Text Key: 82072619
• Report Number: 3010617000-2017-00626
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: health professional,user faci
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2017
• 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: 07/19/2017
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/20/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/22/2016
• 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: 76 YR
• Patient Weight: 85