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

Model Number MODEL 100

Device Problem Visual Prompts will not Clear (2281)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/08/2022

Event Type  malfunction  

Event Description

The customer reported that the autopulse platform (sn unknown) displayed user advisory (ua) 45 (not at "home" position after power-on/restart).Zoll technical support personnel provided instructions to the customer via email to clear the ua45 advisory message.The customer responded stating that the ua45 was cleared.Therefore, the autopulse platform will not be returning to zoll for evaluation.It is unknown when the problem occurred.However, patient use information was requested, but no additional information was provided.

Manufacturer Narrative

The autopulse platform associated with this complaint was not returned to zoll for evaluation.The customer was able to clear the user advisory (ua) 45 (not at "home" position after power-on/restart) with the help and guidance received from zoll technical support.Note that user advisory is normally a clearable error message and is designed into the platform to alert the operator that autopulse has detected one of several conditions.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.

Manufacturer Narrative

B5 (describe event or problem) was updated based on the received additional information.H6 (health effect - clinical code) was corrected based on the received additional information.H6 (health effect - impact code) was corrected based on the received additional information.

Event Description

During device check after patient use, the autopulse platform (sn unknown) displayed user advisory (ua) 45 (not at "home" position after power-on/restart).Zoll technical support personnel responded to the customer's email and provided instructions to clear the ua45.The customer responded reporting that the ua45 advisory message was cleared.The customer was unable to recall the platform's serial number but stated that the platform has been functioning as intended.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: 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: 16080921
• MDR Text Key: 306521266
• Report Number: 3010617000-2022-02107
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/20/2023

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
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0730-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/08/2022
• Initial Date FDA Received: 12/30/2022
• Supplement Dates Manufacturer Received: 01/19/2023
• Supplement Dates FDA Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1