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

Model Number MODEL 100

Device Problem Failure to Power Up (1476)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/10/2022

Event Type  malfunction  

Manufacturer Narrative

The reported complaint of the autopulse platform(sn (b)(4)) will not power on was not confirmed during functional testing.The autopulse platform powers on and passed the functional testing without any fault or error and performed as intended.Upon visual inspection, unrelated to the reported complaint, crack was observed on the front cover at the front end area.The observed physical damage appeared to be characteristic of user mishandling.The front enclosure was replaced to address the observed physical damage.The archive data review showed no significant discrepancies.The autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with multiple good known test batteries until discharged without any fault or error.There were no device deficiencies found during service evaluation that could have caused or contributed to the reported complaint.The customer will be recommended to check the connector of the batteries that were used for any sign of damage, to make sure the battery is fully charged, and to check the battery is firmly inserted into the platform before turning on the autopulse.

Event Description

During shift check, the customer reported the autopulse platform(sn (b)(4)) will not power on.The platform was tested with multiple autopulse li-ion batteries; however, the same issue was observed.No patient involvement.

• Brand Name: AUTOPULSE® RESUSCITATION MODEL 100
• Type of Device: CARDIAC CHEST COMPRESSOR
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood ave; san jose CA 95131
• Manufacturer Contact: kim thoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4084192922
• MDR Report Key: 14046210
• MDR Text Key: 288831610
• Report Number: 3010617000-2022-00321
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000017
• UDI-Public: 00849111000017
• 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
• Report Date: 04/07/2022

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
• Device Operator: Health Professional
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0700-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2022
• Initial Date FDA Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/20/2017
• 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