MAUDE Adverse Event Report: ZOLL CIRCULATION 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 06/15/2022

Event Type  malfunction  

Event Description

During shift check, the autopulse platform (sn (b)(4) does not powers on with multiple fully charged autopulse li-ion batteries.The batteries powers on another autopulse platform with no issues.No patient involvement.

Manufacturer Narrative

The reported complaint of "the autopulse platform (sn (b)(4) does not power on with multiple fully charged autopulse li-ion batteries" was not confirmed during functional test and during archive data review.No device malfunction was observed during the functional testing and the autopulse platform performed as intended.During visual inspection, no physical damage was observed on the autopulse platform.The archive data review indicated multiple user advisory (ua) 12 (lifeband not present) errors, unrelated to the reported complaint.User advisories are clearable error messages; per the battery hangtag - advisory codes description and action, user advisory 12 indicates that the autopulse has detected that the lifeband is not properly installed.The recommended actions for this type of user advisory are: ensure that the band clip (underneath the device) is correctly seated in the driveshaft and can freely rotate after insertion.The autopulse platform passed the initial functional test without any fault or error.Following service, the autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with good known test batteries until discharged without any fault or error.The autopulse platform passed the final testing without any fault or error.

• 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: 14947134
• MDR Text Key: 296051694
• Report Number: 3010617000-2022-00774
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111000512
• UDI-Public: 00849111000512
• 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: 07/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/04/2021
• 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