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

Model Number	MODEL 100
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The customer reported complaint that the lifeband sheath was caught/twisted on to the little black clip on the left side of the platform causing the internal lifeband to twist and jam the mechanism was not confirmed during archive review and functional testing.There were no device deficiencies found during evaluation of the returned platform that could have caused or contributed to the reported complaint.The reported issue might have been caused by the customer's lifeband, which was not return for investigation.Per zoll autopulse user guide, the lifeband must be lifted up to its fullest extension, ensuring that the side bands are at a 90 degree angle to the platform, that they are not twisted and that there are no obstructions.No significant discrepancies were found in the archive data.The platform was functionally tested and there were no problems or error messages noted.During visual inspection damaged load plate cover was noted.The load plate cover was replaced to remedy the physical damage.An additional repair and update was completed (unrelated to the reported complaint) to ensure that the autopulse platform is functional without issue.The load plate cover was replaced to remedy the physical damage.The platform has passed all the final testing.Historical complaints were reviewed for service information related to the reported complaint and there was no previous history of related complaints for autopulse sn (b)(4).
Event or Problem Description
Ottawa paramedic service received a 911 call for a patient.Clothes above the waist were removed, when the platform was placed.No leads/cables/wires etc.Were near or across the lifeband.The autopulse was deployed without any issues and ran for several minutes.As soon as the paramedics unloaded the stretcher at the hospital, the platform stopped performing compressions and error message reset the lifeband was displaying.The customer tried to pull straight up and reset the lifeband; however, the lifeband would not retract.Upon inspection, the customer noted that the lifeband sheath was caught/twisted on to the little black clip on the left side of the platform causing the internal lifeband to twist and jam the mechanism.The customer quickly disconnected the lifeband at the middle and resumed performing manual cpr.No other information was provided.Multiple attempts were made to contact the reporter for additional information; however, were unsuccessful.No further information was provided.No known patient consequences 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: 6390145
• Report Number: 3010617000-2017-00181
• Device Sequence Number: 10998598
• Product Code: DRM
• UDI-Device Identifier: 00849111001274
• UDI-Public: 00849111001274
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Health Professional
• Type of Report: Initial
• Report Date (Section B): 03/08/2017

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: 8700-0740-01-66
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2017
• Initial Report FDA Received Date: 03/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1