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

Model Number MODEL 100

Device Problems Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

The customer reported complaint for the platform displayed an error message user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) was confirmed during archive data review and functional testing.Load cell was found defective and a replacement was required.Visual inspection was performed and found no physical damage to the autopulse platform.The platform failed the initial functional testing due to user advisory (ua) 27 (encoder fault (>3000 rpm)) error message, unrelated to the reported event.Power distribution board (pdb) was replaced to remedy the fault.Following the repair, the platform was further tested with large resuscitation testing fixture, (lrtf) equivalent to 250 pound patient and passed all functional testing criteria and met all required specifications.Review of the archive data indicated multiple error messages (ua) 07 on the customer reported event date.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).The death was not related to the autopulse device.The autopulse is used as an adjunct to manual cpr in cases of clinical death.The benefit of using the autopulse is that it in part substitutes mechanical compressions for the physical labor of manual chest compressions.If the autopulse did not start or unexpectedly stops compressions, rescuer should revert to manual cpr, which is the standard of care.In this case, autopulse platform (sn (b)(4)) exhibited user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message after the patient was placed on the platform.The crew immediately reverted to manual cpr when they can't resolve the issue after performing troubleshooting by pulling the lifeband up and restarting the platform.Manual cpr continued compressions for 10 minutes until second autopulse platform was used.Second platform was used for approximately 20 minutes without issues while in transport to the hospital.Rosc (return of spontaneous circulation) was not achieved.The patient is deceased but the caller does not feel it is related to the device.The autopulse was intended to be used as an adjunct to manual cpr on adult patients.In case of stoppage of autopulse the user reverts to manual cpr.The transition from autopulse to manual cpr by trained users is similar to the time necessary for rescuer rotation, and presents the same workflow as manual cpr.Hence, based on available information, the patients' outcome was not negatively impacted by the interruptions when compared to standard of care manual cpr.

Event Description

During the call, the autopulse platform (sn (b)(4)) was used on a (b)(6) male patient.The autopulse platform exhibited user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message after the patient was placed on the platform.The autopulse platform displayed message with a "please lift lifeband and restart" prompt.The user was unable to resolve the issue after performing troubleshooting by pulling the lifeband up and restarting the platform.The crew immediately reverted to manual cpr and continue compressions for 10 minutes until second autopulse platform was used.Second platform was used for approximately 20 minutes while in transport to the hospital.Rosc (return of spontaneous circulation) was not achieved and patient was pronounced shortly after arrival by an emergency room physician.The cause of death was not specified.According to the reporter, the patient's death was not related to the delay caused by the device issue.After return to the station, customer tried to test device with manikin, autopulse platform displayed user advisory (ua) 07 error message and customer was unable to clear the error message after exchanging multiple lifebands.

• 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: 7590010
• MDR Text Key: 110707223
• Report Number: 3010617000-2018-00629
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• 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: 05/25/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/07/2017
• 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: 71 YR