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

Model Number MODEL 100

Device Problems Overheating of Device (1437); Inadequate Storage (1600); Visual Prompts will not Clear (2281); Device Operational Issue (2914)

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

Event Date 12/24/2016

Event Type  malfunction  

Manufacturer Narrative

The report of the autopulse platform (sn (b)(4)) displaying a user advisory (ua) 11 (max patient temperature exceeded) error message and subsequently shutting down was confirmed based on the evaluation of the archive data retrieved from the platform; however, the reported event was not reproduced during functional testing of the platform.There were no device deficiencies found during functional testing which could have caused or contributed to the reported ua 11 error message.Therefore, a root cause of the ua 11 error message could not be determined.However, possible causes could be due to the ambient temperature being outside of operating parameters or the vents underneath the platform are blocked.Review of the archive data retrieved from the platform indicated a user advisory (ua) 11 (max patient temperature exceeded) error message.The platform was functionally tested and powered on without any error message observed.The ua 11 was not observed.Multiple tests were performed and showed that the platform's temperature sensor is functioning properly.The thermal management system maintains the platform's internal temperatures to prevent patient surface temperatures in excess of the allowed threshold.Note that the user advisory error messages are designed into the platform when one of several conditions is detected.The ua 11 error message observed in the archive data can be cleared by allowing the platform to cool down and performing the power on self test (post).Additionally, further functional testing of the platform revealed a system error 139 (unable to hold compression position) message on the display screen during run-in test, which was unrelated to the reported event.The system error message was due to the drive train motor brake assembly being out of specification.After the component was replaced, the platform was re-evaluated and operated with continuous compression using a light resuscitation test fixture without any observed errors.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse platform with serial number (b)(4).The autopulse platform is a reusable device and was manufactured on nov 2012.

Event Description

It was reported by the customer that multiple incidence of the autopulse platform (sn (b)(4)) overheating and powering off were observed during patient use on (b)(6) 2016.No known patient consequence was reported.Multiple attempts were made to obtain further information but have been unsuccessful.

• 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: 6306160
• MDR Text Key: 66658098
• Report Number: 3010617000-2017-00102
• 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
• Report Date: 02/06/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2017
• 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: 01/26/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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