MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LI-ION BATTERY

Model Number 8700-0752

Device Problems Failure to Power Up (1476); Battery Problem (2885)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/07/2017

Event Type  malfunction  

Manufacturer Narrative

Zoll has not yet received the autopulse battery for evaluation.A supplemental report will be filed if and when the product is returned and investigation has been completed.The death was not related to the autopulse system.The autopulse is used as an adjunct to manual cpr in cases of clinical death.The benefit of using the autopulse is that it in part substitutes mechanical compressions for the physical labor of manual chest compressions.If the autopulse did not start or unexpectedly stops compressions, rescuer should revert to manual cpr, which is the standard of care.In this case, autopulse did not perform compression.Crew resorted to manual compressions.For a trained user, changing from the autopulse to manual cpr can be made quickly, and the patient's outcome should not be negatively impacted when compared to standard of care manual cpr.Patient was not revived by manual cpr.No detail was provided for the patient's clinical condition.However, the patient's death is most likely caused by the underlying condition of the patient.

Event Description

During a response call, the autopulse lithium ion battery (sn: (b)(4)) did not power on the autopulse platform (sn: unknown).The responding team reverted to manual cpr.According to the reporter, the patient would not have survived even if the platform was utilized.The charging status of the battery at the time of the event is not known.Multiple follow-up attempts were made to obtain additional information from the customer, however, were unsuccessful.No further information was provided.Autopulse platform reported under mfr 3010617000-2018-00047.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: LI-ION BATTERY
• 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: 7170363
• MDR Text Key: 96600431
• Report Number: 3010617000-2018-00001
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• 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 faci
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0752
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/08/2017
• Was Device Evaluated by Manufacturer?: No
• 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