MAUDE Adverse Event Report: ZOLL CIRCULATION INC 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 Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2018
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
The autopulse platform ((b)(4)) displayed a "system error, out of service, revert to manual cpr" message.The reporter was unable to specify if the issue occurred during shift check or patient use.No known impact or patient consequence was reported.
Additional Manufacturer Narrative
The report of the autopulse platform (sn (b)(4) displaying a system error, out of service, revert to manual cpr message was confirmed during functional testing and archive data review; the root cause was due to a defective processor board.Evaluation of the platform during initial power up, revealed a system error, out of service, revert to manual cpr message on the user control panel.It was indicated that the processor board was defective.The archive data was reviewed and contained a system error 136 (internal parameter corrupted).As part of routine service during testing, the platform was further examined and found damaged load plate cover.This physical damage found during visual inspection is a characteristic of normal wear and tear for the age of the device.This observation is not related to the reported event.The autopulse platform is a reusable device and was manufactured on 26 oct 2004.It has exceeded its expected service life of 5 years.The platform is 13 years old and has not seen regular preventive maintenance.Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for the autopulse platform with serial number (b)(4).

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave,; san jose CA 95131
• MDR Report Key: 7535548
• Report Number: 3010617000-2018-00495
• Device Sequence Number: 1512302
• Product Code: DRM
• UDI-Device Identifier: 00849111000239
• UDI-Public: 00849111000239
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 07/31/2018

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: 8700-0700-1X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 07/31/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention