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

Model Number	MODEL 100
Medical Device Problem Code	Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/15/2016
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 to zoll that during use on a patient, the lifeband on the autopulse (s/n (b)(4)) tightened to approximately 10cm, then stopped working.The customer reported that the autopulse displayed 2 alert messages: check patient location and check lifeband.No information regarding the patient or the outcome was given by the customer at the time of this report.The device was sent to (b)(4) (distributor) for testing, but while using a mannequin, the reported error messages could not be duplicated.The device is reported to be working appropriately during testing.
Additional Manufacturer Narrative
The autopulse platform (s/n (b)(4)) was returned to zoll for investigation on 02/26/2016.Visual inspection of the returned platform was performed and no physical damages were noted upon receipt.A review of the archive was performed based on the information reviewed, user advisory 18 - max take up resolution exceeded, user advisory 12 - life-band not present, user advisory 2 - compression tracking error occurred on the first compression, user advisory 7 - discrepancy between load1 and load2 too large and belt clip not detected in spool shaft were noted.Functional testing was performed and device passed the test without any fault or error report.Functional testing was performed and device passed functional testing without any fault or error observed.In summary the customer's reported complaint was confirmed.The exact root cause for the reported complaint could not be determined.Base on the platform's archive, observed ua-7 can be result of patient not placed on device correctly or possible movement of patient or board.No load change was detected at the load plate.Also, ua 12 - lifeband not present was noted during the date of the problem reported.It was also inspected and verified that the two screws of the life band clip reset switch which hold the lever parallel to the switch case are torqued to specification.Using a standard belt clip tool, it was verified if the switch closes and that the platform does not fault to user advisory 12.The brake gap inspection was performed and verified that the brake gap was within the specification.A run_in testing was performed using the 95% patient test fixture (lrtf) for several hours, and device did not duplicate any of the user advisory or fault.In summary, the autopulse has passed all the testing and meets all required specifications.
Additional Manufacturer Narrative
The autopulse platform (s/n (b)(4)) was returned to zoll for investigation on 02/26/2016.Visual inspection of the returned platform was performed and no physical damages were noted upon receipt.A review of the archive was performed based on the information reviewed, user advisory 18 - max take up resolution exceeded, user advisory 12 - life-band not present, user advisory 2 - compression tracking error occurred on the first compression, user advisory 7 - discrepancy between load1 and load2 too large and belt clip not detected in spool shaft were noted.Functional testing was performed and device passed the test without any fault or error report.Functional testing was performed and device passed functional testing without any fault or error observed.In summary the customer's reported complaint was confirmed.The exact root cause for the reported complaint could not be determined.Base on the platform's archive, observed ua-7 can be result of patient not placed on device correctly or possible movement of patient or board.No load change was detected at the load plate.Also, ua 12 - lifeband not present was noted during the date of the problem reported.It was also inspected and verified that the two screws of the life band clip reset switch which hold the lever parallel to the switch case are torqued to specification.Using a standard belt clip tool, it was verified if the switch closes and that the platform does not fault to user advisory 12.The brake gap inspection was performed and verified that the brake gap was within the specification.A run_in testing was performed using the 95% patient test fixture (lrtf) for several hours, and device did not duplicate any of the user advisory or fault.In summary, the autopulse has passed all the testing and meets all required specifications.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION, INC; 2000 ringwood avenue; san jose CA 95131
• MDR Report Key: 5499369
• Report Number: 3010617000-2016-00165
• Device Sequence Number: 1135633
• Product Code: DRM
• UDI-Device Identifier: 00849111000697
• UDI-Public: 00849111000697
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Service Personnel
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/25/2016

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: 8700-0730-21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/26/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/18/2016
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/14/2016
• Supplement Report FDA Received Date: 04/22/2016; 04/25/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1