MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LIFEBAND; CHEST COMPRESSION ASSEMBLY

Model Number	8700-0701
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The autopulse lifeband (s/n (b)(4)) was returned to zoll for evaluation.Visual investigation was performed and found the breakaway link broken.The breaking of breakaway link on the lifeband is a designed safety feature to prevent over compression.As the drive shaft rotates and shortens/tightens the lifeband, compresses the patient's chest.Should one side of the lifeband get caught/jammed in the belt guard during the compression, the load sensors do not see the expected increase in load.Consequently, the breakaway link will separate and prevent compressions to continue.The autopulse user guide instructs that if the bands cannot be closed, to revert to manual cpr.
Event or Problem Description
It was reported that the lifeband (s/n: (b)(4)) was placed on a patient who suffered a cardio-pulmonary arrest.According to the customer, no sooner was the autopulse powered on a "pop" was heard and the lifeband snapped.The use of the autopulse platform was discontinued and another chest compressions system (lucas) was started and continued.No known patient consequences were reported.

• Brand Name: AUTOPULSE® LIFEBAND
• Common Device Name: CHEST COMPRESSION ASSEMBLY
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• MDR Report Key: 5884739
• Report Number: 3010617000-2016-00584
• Device Sequence Number: 11138860
• Product Code: DRM
• UDI-Device Identifier: 00849111065016
• UDI-Public: 00849111065016
• 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: consumer,foreign,health profe
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/17/2016

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: 8700-0701
• Device Catalogue Number: 8700-0701-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2016
• Initial Report FDA Received Date: 08/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1