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

Model Number	MODEL 100
Medical Device Problem Codes	Device Stops Intermittently (1599); Visual Prompts will not Clear (2281); Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/05/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The autopulse platform in complaint was returned to zoll on (b)(4) 2016 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.
Event or Problem Description
It was reported that during patient use the autopulse platform (s/n (b)(4)) stopped functioning after 3-4 compressions.The customer repeated the restart process a few times until the device displayed a system error at which time the use of the autopulse was suspended.The crew had to revert to manual cpr.No patient information was disclosed.No further information was provided.
Additional Manufacturer Narrative
The autopulse platform (s/n (b)(4)) was returned to zoll (b)(4) on 01/20/2016 for evaluation.Device history record (dhr) was reviewed and no previous related complaint was reported for this autopulse platform (s/n (b)(4)).A visual inspection of the returned platform was performed and no visible damages were observed.A review of the autopulse's archive was performed and it showed latch error139 (unable to hold compression position) occurring on the reported event date of (b)(6) 2015, thus confirming the reported complaint.The platform was functionally tested and found the drive train brake gap was out of specification was at fault.Further investigation indicated that the brake gap was not able to adjust to its specification and the encoder dimple locking hole would not lock and caused the brake to disengage.In summary, the customer's reported complaint was confirmed during archive review and functional testing.The root cause was determined to be a defective drive train and clutch plate.After the drive train and clutch plate were replaced, the platform passed testing and met all required specifications.

• 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: 5411791
• Report Number: 3010617000-2016-00057
• Device Sequence Number: 13566200
• Product Code: DRM
• UDI-Device Identifier: 00849111065108
• UDI-Public: 00849111065108
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Followup
• Report Date (Section B): 03/30/2016

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: 8700-0700-03-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/04/2016
• Supplement Report FDA Received Date: 03/31/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1