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); Physical Resistance/Sticking (4012)

Patient Problem No Patient Involvement (2645)

Event Date 04/15/2019

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.In addition, the corrosion was present on the drive train motor and the motor drive train brake completely locked due to the built rust, thus confirming the customer reported complaint of the lifeband unable to retract.Visual inspection was performed and found extensive corrosion and fluid damage inside the top cover, and front and bottom enclosure, unrelated to the reported issue.Per autopulse user guide, 4.2.Cleaning the autopulse platform section: "wipe all the surfaces of the autopulse platform free of foreign matter and spills with a disinfectant or bactericidal wipe.Check the vents to ensure that they are free and clear of any obstructive matter.Caution: do not submerge the autopulse in liquid.Ensure that the autopulse is dry before storing." during functional testing, user advisory (ua) 07 error message displayed upon power on the device, thus confirming the reported complaint.The load characterization check was performed and verified that one of the load cells is out of specification.Review of the archive data indicated multiple error messages user advisory (ua) 07 around the customer reported event date.Due to the received condition of the device, no further service will be performed on the platform.The device will be returned to the customer labeled "not for clinical use".Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of reported complaints for autopulse platform sn (b)(4).

Event Description

During shift check, the autopulse platform (sn (b)(4)) displayed user advisory (ua) 07 (discrepancy between load 1 and load 2 too large) error message and the lifeband would not retract.No patient involvement.

• 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: 8589270
• MDR Text Key: 144607573
• Report Number: 3010617000-2019-00371
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/07/2019

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: 8700-0730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/15/2019
• Initial Date FDA Received: 05/07/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2016
• 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