MAUDE Adverse Event Report: ZOLL CIRCULATION 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	04/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported complaint of system error, out of service, revert to manual cpr error message was confirmed based on the archive review and during functional testing.The fault was found to be due to the defective motor drive train.Visual inspection was performed and found the screw post is damaged.One screw post is completely broken and in bits and the screw post cannot be repaired.The physical damage found during visual inspection is considered unrelated to the reported event.The autopulse platform is a reusable device and was manufactured on 09-jan-2017.A review of the archive was performed and the reported complaint of the system error, out of service, revert to manual cpr was confirmed.The archive data shows ua139 (latched system error) occurred on the reported event date due to the autopulse is unable to maintain compression position/depth is likely caused by an internal component malfunctioned.Functional testing was performed and the reported issue of system error, out of service, revert to manual cpr error message was confirmed.The autopulse stops several times on the normal manikin with ua17.The autopulse did not reach target depths within specification and it was due to the defective motor drive train.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of complaints reported for autopulse platform serial number (b)(4).
Event or Problem Description
During patient use, the autopulse platform ((b)(4)) performed continuous compression for an unspecified amount of time and then displayed "system error, out of service, revert to manual cpr" message.No known impact or consequence to the patient was reported.

• 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: 7513042
• Report Number: 3010617000-2018-00544
• Device Sequence Number: 13801866
• Product Code: DRM
• UDI-Device Identifier: 00849111001274
• UDI-Public: 00849111001274
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 05/14/2018

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: 8700-0740-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2018
• Initial Report FDA Received Date: 05/14/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1