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

Model Number	MODEL 100
Medical Device Problem Codes	Device Displays Incorrect Message (2591); Device Operational Issue (2914)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/09/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation on the autopulse platform (sn: (b)(4)) is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
During service on an autopulse platform (sn: (b)(4)), the service technician reported that the autopulse displayed a user advisory (ua) 16 (timeout moving to take-up position) and ua 18 (max take-up revolution exceeded) error message.There was no patient involvement.
Additional Manufacturer Narrative
The customer reported complaint for the autopulse platform displaying an error message user advisory (ua) 16 (timeout moving to take-up position) was confirmed during initial functional testing but not during archive review.Both load cells were replaced to remedy the issue.The secondary complaint for the platform displaying an error message ua 18 (max take-up revolution exceeded) was not confirmed during archive review and initial functional testing.User advisory error messages are designed into the platform when one of several conditions is detected.Ua 18 (max take-up revolutions exceeded) alerts the user that the drive shaft moved the lifeband past the maximum allowable take up depth without detecting a patient.Visual inspection was performed and damaged top cover and short black cover were noted, unrelated to the reported complaint.The autopulse platform is a reusable device; therefore, this type of damage is characteristic of normal wear and tear for the life of the device.The archive data review shows no session occurred on the reported event date of (b)(4) 2017.During functional testing, ua 16 was observed.In addition, the load cell characterization tsting shows both load cells readings were not within specification.An additional repair and update was completed (unrelated to the reported complaint) to ensure that the autopulse platform is functional without issue.The top cover and short black covers were replaced, after which the platform passed all the final testing.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaints for autopulse sn (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 7104153
• Report Number: 3010617000-2017-01113
• Device Sequence Number: 19197752
• Product Code: DRM
• UDI-Device Identifier: 00849111000154
• UDI-Public: 00849111000154
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2018

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
• Operator of Device: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-11
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2017
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/14/2017
• Supplement Date Received by Manufacturer: 02/01/2018
• Initial Report FDA Received Date: 12/11/2017
• Supplement Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1