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

Model Number	MODEL 100
Medical Device Problem Code	Visual Prompts will not Clear (2281)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/06/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The autopulse platform involved in the reported complaint will not be returned to a zoll service depot for evaluation.The device was investigated and serviced by a zoll trained distributor in brazil.The damaged/failed drive train was replaced to remedy the user advisory (ua) 45 (not at "home" position after power-on/restart) error message.Since the issues were resolved, service was not required to be performed by zoll.
Event or Problem Description
During shift check, the autopulse platform (b)(6) displayed a user advisory (ua) 45 (not at "home" position after power-on/restart) error message.Additionally, the customer reported when trying to fully lift/extend the lifeband, a lot of force is required.When inserting the belt clip test, the drive shaft does not rotate freely in both directions.On evaluation, biomed found that the motor shaft is bent, and the clutch does not turn evenly.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLLCIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 16862965
• Report Number: 3010617000-2023-00392
• Device Sequence Number: 20322934
• Product Code: DRM
• UDI-Device Identifier: 00849111000659
• UDI-Public: 00849111000659
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K112998
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 05/03/2023

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: 8700-0730-24
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/10/2023
• Initial Report FDA Received Date: 05/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown