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

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer's reported complaint of autopulse platform ((b)(4)) platform stopped compressions and displayed user advisory (ua) 02 (compression tracking error) error message was confirmed during archive review and functional testing.Defective drivetrain motor was replaced to remedy the issue.Review of the archive data indicated multiple error messages user advisory (ua) 02, user advisory (ua) 08 and user advisory (ua) 41 occurred on (b)(6) 2018, rather than on the reported event date is given by the customer of (b)(6) 2018.A customer reported user advisory (ua) 08 (motor controller fault detected) and user advisory (ua) 41 (patient temperature sensor failure) could not be confirmed during functional testing, however, was confirmed in the archive review.The motor controller board was replaced to avoid a reoccurrence of user advisory (ua) 08 error message.There were no device deficiencies found during the evaluation of the platform, which could have caused or contributed to the reported (ua) 41 error message.The storage and shift check conditions are not known; however, factors such as ambient storage condition (e.G., fire truck in sun) or soft surface that may block air vents are known to cause ua 41 error messages in rare cases.Visual inspection was performed and found no damage upon receipt.Following the service and repair, the autopulse was tested functionally and passed successfully with no issue or faults observed.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of related complaints for autopulse sn (b)(4).
Event or Problem Description
During the call, the autopulse platform ((b)(4)) stopped compressions after displaying user advisory (ua) 02 (compression tracking error), user advisory (ua) 08 (motor controller fault detected) and user advisory (ua) 41 (patient temperature sensor failure) error messages.The crew immediately reverted to manual cpr for an unknown period of time until the second autopulse platform was used to continue compressions.No known patient consequences were reported.No other information was provided.

• 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: 7856697
• Report Number: 3010617000-2018-00912
• Device Sequence Number: 1950545
• Product Code: DRM
• UDI-Device Identifier: 00849111000291
• UDI-Public: 00849111000291
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2018

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: 8700-0700-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2018
• Initial Report FDA Received Date: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1