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

Model Number	MODEL 100
Medical Device Problem Codes	Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the autopulse platform in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.
Event or Problem Description
It was reported that during a shift check and upon powering up the device, the autopulse platform (s/n (b)(4)) displayed user advisory (ua) 7 (discrepancy between load 1 and load 2 too large) error message.No patient involved was reported with this event.No additional information provided.
Additional Manufacturer Narrative
The autopulse platform (s/n (b)(4)) was returned to zoll for evaluation.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaint reported for autopulse with serial number (b)(4).A visual inspection of the returned autopulse platform was performed and found patient restraint wires, short black cover, battery bay screw post and internal screw post were damaged.Additionally, there was blood contamination and corrosion of internal metal coating was observed.The autopulse platform is a reusable device and was manufactured on 02/16/2007.Therefore, this type of physical damages found during visual inspection is characteristic of normal wear and tear for the life of the device and is not related to the reported complaint.A review of the platform was performed and no abnormalities were noted.During functional testing ua7 message was observed upon power-up.Further testing showed that one of the load cell modules was defective resulting in the platform displaying a ua 7 message.In summary, the customer's reported complaint of autopulse displaying user advisory 7 was confirmed during functional testing.The root cause for ua 7 was determined to be due to a defective load cell module.After replacing both modules, the platform passed load cell characterization test.The platform passed all final testing criteria.

• 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: 5563565
• Report Number: 3010617000-2016-00239
• Device Sequence Number: 485968
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2016

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: 06/01/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/08/2016
• Supplement Report FDA Received Date: 06/26/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1