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

Model Number MODEL 100

Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)

Patient Problems Cardiac Arrest (1762); Death (1802); Sepsis (2067)

Event Type  malfunction  

Event Description

It was reported that a (b)(6) year old female patient weighing (b)(6), suffered acute sepsis leading to cardiac arrest.This incident occurred in the icu at medical center of the rockies.The patient was being monitored at the time by a beside monitor, which immediately sounded an alarm to notify the care team that the patient was in distress.Manual cpr was performed by members of the care team (exact length of time was not provided).The autopulse was located outside the patient's room approximately 20 feet away.The patient was placed onto the autopulse platform without any issues.To ensure correct placement, the user checked both the patient and lifeband positions.The autopulse platform failed to initiate compressions and immediately displayed a user advisory (ua) 12 (lifeband not present) message.User pulled up the lifeband and pressed restart multiple times, however the issue would not resolve.Use of the autopulse was discontinued.Manual cpr was resumed for unknown length of time.Rosc (return of spontaneous circulation) was never achieved.The patient was pronounced by the critical care physician in the icu.Additional patient history and medications were not provided.The cause of death is unknown.It is unknown if an autopsy was performed.Customer received confirmation from the icu care team, that the autopulse did not contribute to the patient's death.Manufacturer has requested additional information from the customer; however, further information has not yet been obtained.Please note that customer believes that the date of event is (b)(6) 2015, however, manufacturer has requested confirmation of this.

Manufacturer Narrative

Product in complaint was returned to zoll on (b)(4) 2015 for investigation.However, investigation is still in progress.A supplemental report will be filed once investigation has been completed.Based on the reported information, the patient did not achieve rosc with either manual or mechanical compression.Review of all available information to date, medical judgment and confirmation from the customer, use of the autopulse device did not cause or contribute to death.

Manufacturer Narrative

The autopulse platform (s/n (b)(4)) was returned to the manufacturer for evaluation.Visual inspection of the returned platform was performed and found no damage to the platform.The reported user advisory (ua) 12 (lifeband not present) was observed upon power up of the platform, thus confirming the reported complaint.Further inspection identified the cause to be that the two screws of the lifeband clip that hold the lever parallel to the switch case were loose.The lifeband clip detect switch was readjusted by tightening the screws and no other user advisories or warnings were observed.Load cell characterization testing was also performed and it was found that both load cell modules are functioning within specification.The platform was also run with a 95% patient test fixture (lrtf) for several hours and no other faults were observed.Even though the customer was unable to provide the exact date of event, a review of the platform's archive data showed that multiple user advisories (uas) such as: 2 (compression tracking error), 12 (lifeband not present), 20 (position out of range) and 45 (not at "home" position after power-on/restart) occurred on (b)(6) 2015.Per autopulse technical service guide (p/n 11377-006), a ua2 is exhibited when the platform detects a change in lifeband tension.This advisory happens when either the patient or the lifeband is out of position, or if the lifeband is opened during active operation.Ua20 and ua45 are both exhibited when the lifeband is not fully extended before pressing start.No parts needed to be replaced to remedy the customer reported complaint.However, the two screws of the lifeband clip reset switch, which hold the lever parallel to the switch case were tightened to resolve the reported user advisory (ua) 12.In summary, the reported complaint was confirmed upon functional testing as well as during platform archive review and attributed to the two screws of the lifeband clip reset switch, which holds the lever parallel to the switch case were loose.Following service, including tightening the two screws, the platform passed all test criteria.

• 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: 4542153
• MDR Text Key: 5544036
• Report Number: 3010617000-2015-00104
• Device Sequence Number: 1
• Product Code: DRM
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2015

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: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/25/2015
• Initial Date FDA Received: 02/24/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2006
• 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: 31 YR
• Patient Weight: 124