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 Operates Differently Than Expected (2913)

Patient Problems Cardiac Arrest (1762); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll (b)(4) for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Event Description

It was reported that during patient use, the autopulse platform was unable to perform compressions and displayed a user advisory (ua) 12 (lifeband not present) message.Customer reverted to manual cpr (exact length of time was not provided).No adverse patient sequelae was reported.No further information was provided.Please note that the date of event was not provided by the customer.

Manufacturer Narrative

The autopulse platform was returned to zoll (b)(4) for evaluation on (b)(4) 2015.Visual inspection of the returned platform was performed and no physical damages were observed.A review of the platform's archive data was performed and the customer's reported complaint of the autopulse platform displaying a user advisory (ua) 12 (lifeband not present) message was confirmed as multiple user advisory (ua) 12 messages were observed.The platform was functionally tested and the reported complaint was not duplicated as the platform displaying a user advisory (ua) 12 (lifeband not present) was not observed.As a precaution the two screws of the lifeband clip reset switch, that hold the lever parallel with the switch case were inspected and torqued to specification.Using a standard belt clip tool, it was verified that the switch was able to close and that the platform does not exhibit a user advisory (ua) 12 fault.A run-in testing was also performed using a 95% large resuscitation test fixture (lrtf) and no user advisory or warnings were exhibited.Load cell characterization was also performed, which showed that both load cells were functioning within specification.Based on the investigation, no parts were replaced to remedy the customer's reported complaint.In summary, the customer's reported complaint was confirmed during platform archive review.A root cause for the platform displaying a user advisory (ua) 12 could not be determined.However, as a precaution the lifeband clip detect switch was inspected and adjusted to ensure that the platform is functioning properly and does not exhibit another ua 12.Per the autopulse maintenance guide (p/n: 11653-001), user advisory 12 is an indication that the autopulse has detected that the lifeband is not properly installed.The recommended actions to take for this type of user advisory are: ensure that the band clip (underneath the device) is properly seated in the drive shaft and the drive shaft can freely rotate after insertion.The customer indicated that rosc was never achieved with manual compressions, which is the standard of care and the autopulse platform was unable to be used as a result of the user advisory (ua) 12.Therefore, the customer did not attribute the patient's death to use of the autopulse device.

Event Description

Additional information was received on 08/05/2015: the autopulse was used on a cardiac arrest patient.The age, gender, weight and height of the patient are unknown.The patient's medical history is also unknown.It was reported that ems performed manual cpr (exact length of time was not provided) until arrival at the hospital.The hospital staff attempted to use the autopulse platform, however a user advisory (ua) 12 (lifeband not present) message was displayed.Rosc (return of spontaneous circulation) was never achieved.The physician does not attribute the patient's death to the autopulse.

• 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: 4937163
• MDR Text Key: 22742264
• Report Number: 3010617000-2015-00413
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Report Date: 07/01/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/23/2015
• 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: 8700-0700-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/27/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/10/2011
• 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