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

Model Number	MODEL 100
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/23/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The autopulse platform (sn unknown) was used to resuscitate a patient in cardiac arrest.The user installed the new lifeband (lot# unknown) to use with the platform, however, the platform could not make compressions.The crew reverted to manual cpr for the rest of the call.No consequences or impact to the patient.Upon returning to the ems center, the crew noticed that the lifeband band clip that snaps into the autopulse platform was broken.Please see the following related mfr report: mfr #3010617000-2022-00249 for the autopulse lifeband.
Additional Manufacturer Narrative
The device associated with this complaint will not be returned for evaluation.After the call, the autopulse platform was checked and the lifeband was observed with the broken band clip.The platform was verified to be functional and have been used by the user without issues.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Common Device Name: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION; 2000 ringwood ave.; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192922
• MDR Report Key: 13749163
• Report Number: 3010617000-2022-00317
• Device Sequence Number: 20076239
• Product Code: DRM
• UDI-Device Identifier: 00849111000550
• UDI-Public: 00849111000550
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/11/2022

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: 8700-0730-02
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 03/12/2022
• 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