MAUDE Adverse Event Report: ZOLL CIRCULATION 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	04/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The autopulse platform (sn (b)(4)) involved in the reported complaint will not be returned for evaluation because the customer cleared the reported user advisory (ua) 45 (not at "home" position after power-on/restart) error message followed by different user advisories (ua19 (max applied load exceeded) or ua12 (lifeband not present), or ua06 (max battery temperature exceeded) messages) by following the instructions provided by the zoll personnel.After clearing the error message, the customer tested the autopulse platform, and it worked as intended.Therefore, service was not required to be performed by zoll.The autopulse platform was placed back in service for clinical use.User advisory is a clearable error message; per the autopulse® resuscitation system model 100 user guide, if the driveshaft is not at its home position when the autopulse is powered on, a user advisory (45) will occur.This user advisory will persist until the driveshaft is returned to its home position.To clear a user advisory (45), pull up on the lifeband until the chest bands are fully extended (thereby moving the driveshaft back to its home position), and then restart.Per the autopulse user advisory list, user advisory 06 indicates that the battery's internal temperature is too high.The recommended actions for this type of user advisory are removing the battery from the autopulse and allowing it to cool, inserting a new battery in autopulse, and then restarting.User advisory 19 indicates that the load plate has detected too much weight being applied.The recommended actions for this type of user advisory are: ensure the patient/manikin is aligned correctly and then restart.Per the battery hangtag - advisory codes description and action, user advisory 12 indicates that the autopulse has detected that the lifeband is not installed correctly.The recommended actions for this type of user advisory are: ensure that the band clip (underneath the device) is seated correctly in the driveshaft and can freely rotate after insertion.
Event or Problem Description
When replacing the lifeband during the shift check, the autopulse platform (b)(4) stopped after performing a few compressions.Upon restarting, the autopulse platform displayed user advisory (ua) 45 (not at "home" position after power-on/restart).Following ua45, the autopulse platform continued to switch from one ua to another (ua19 (max applied load exceeded) or ua12 (lifeband not present), or ua06 (max battery temperature exceeded) messages).The customer was able to clear the error messages with the help of the zoll tech support personnel via phone.The autopulse platform was placed back in service for clinical use.No patient involvement.

• 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: 14258312
• Report Number: 3010617000-2022-00428
• Device Sequence Number: 12143553
• Product Code: DRM
• UDI-Device Identifier: 00849111000277
• UDI-Public: 00849111000277
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/29/2022

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: 8700-0700-01-66
• 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: 04/07/2022
• Initial Report FDA Received Date: 05/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2008
• 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