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

Model Number MODEL 100

Device Problems Failure to Power Up (1476); Power Problem (3010)

Patient Problem Insufficient Information (4580)

Event Date 04/28/2022

Event Type  malfunction  

Manufacturer Narrative

The customer reported a complaint that "the autopulse platform (b)(4) did not power on intermittently using the autopulse li-ion batteries" was not confirmed during the functional testing and based on the review of the archive data.The autopulse platform passed the initial functional testing and worked as intended.During visual inspection, noticed a cracked front enclosure, unrelated to the reported complaint.The observed damage appeared to be the characteristics of user mishandling such as a drop.The front enclosure needs to be replaced to remedy the observed issue.The autopulse platform passed the functional testing without any fault or error.The autopulse platform passed the run-in test using the 95% patient large resuscitation test fixture (lrtf) with several batteries until discharged without any fault or error.In addition, the platform was tested with returned battery (b)(4) and was able to power on the platform without any issue.The autopulse platform battery connector was checked and confirmed without any damage.Multiple tests were performed for the autopulse platform power on switch.The switch was verified to be fully functional.A review of the archive data showed no occurrences of the autopulse platform not powering on.The autopulse li-ion battery (b)(4) used around the reported event date powered on the autopulse without any issues, thus not confirming the reported complaint.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.Waiting for customer's approval for service repair.

Event Description

The customer reported that the autopulse platform (b)(4) does not power on with four fully charged autopulse li-ion batteries (b)(4).The issue was observed intermittently.It is unknown where the problem occurred.However, patient use information was requested but no additional information was provided.Please see the following related mfr reports: mfr 3010617000-2022-00587 for autopulse li-ion battery (b)(4), mfr 3010617000-2022-00588 for autopulse li-ion battery (b)(4), mfr 3010617000-2022-00589 for autopulse li-ion battery (b)(4), mfr 3010617000-2022-00590 for autopulse li-ion battery (b)(4).

• 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: 14484588
• MDR Text Key: 292515111
• Report Number: 3010617000-2022-00578
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001076
• UDI-Public: 00849111001076
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/23/2022

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: 8700-0740-16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/28/2022
• Initial Date FDA Received: 05/24/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/06/2015
• 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