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 Known Impact Or Consequence To Patient (2692)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not received the product for investigation.A supplemental report will be filed when the product is returned and investigation has been completed.
Event or Problem Description
As reported, the patient was reanimated with the autopulse platform (sn unknown), after an interruption of the resuscitation due to a re-positioning of the patient by doctors and nurses, the autopulse platform displayed user advisory - ua 12 (lifeband not present) error message.The resuscitation was interrupted by pressing the red cancel button.No known impact or consequence to patient.
Additional Manufacturer Narrative
The reported complaint of user advisory - ua12 ((lifeband not present) on the autopulse platform (sn (b)(4) was confirmed during archive data review but not during functional test.Unrelated to the reported complaint, a flickering lcd backlight and encoder drive shaft does not rotate smoothly, exhibits binding and resistance were observed during visual inspection.To remedy the lcd issue identified, the top cover with fluid ingress that corroded the metal part of the platform was replaced.And also, the sticky encoder drive shaft was deburred.Review of the archive data retrieved from the platform shows multiple ua12 occurred on the reported event date on (b)(6) 2018.Thus, confirming the reported complaint.Note that user advisory error messages are designed into the platform when one of several conditions is detected.Ua 12 error message alerts the lifeband is not properly installed.This can be cleared by ensuring that the lifeband is properly installed and restarting the platform.The initial functional testing of the ap platform passed all functional tests and ready for clinical use.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for autopulse with serial number (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: 7749806
• Report Number: 3010617000-2018-00787
• Device Sequence Number: 1171198
• Product Code: DRM
• UDI-Device Identifier: 00849111000536
• UDI-Public: 00849111000536
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/21/2018

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: 8700-0730-08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2018
• Initial Date Received by Manufacturer: 06/19/2018
• Supplement Date Received by Manufacturer: 08/30/2018
• Initial Report FDA Received Date: 08/05/2018
• Supplement Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1