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

Model Number	MODEL 100
Medical Device Problem Codes	No Display/Image (1183); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/03/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zoll has not yet received the autopulse platform for evaluation.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 the metal restraint on the upper housing broke and the display's backlight does not work.There was no patient involvement reported.
Additional Manufacturer Narrative
The reported event was confirmed based on the functional testing of the autopulse platform (sn (b)(4)).The root cause is due to a defective processor board.The autopulse platform is a reusable device and was manufactured on 05 may 2011 and has exceeded its expected service life of 5 years.Functional testing of the platform during initial power up revealed that the lcd backlight on the display screen was not functioning.The issue was attributed to a defective processor board.Additionally, as part of routine service during testing, the platform was examined and cosmetic damages were observed.These observations were unrelated to the primary complaint.Following replacement of the components, the platform was further tested and passed all functional testing criteria and met all required specifications.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).

• 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: 6143432
• Report Number: 3010617000-2016-00868
• Device Sequence Number: 1076058
• 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: foreign,health professional,u
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/21/2017

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: 02/23/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 11/09/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/02/2016
• Supplement Report FDA Received Date: 04/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1