MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® LI-ION BATTERY; LI-ION BATTERY, PRODUCT CODE: DRM

Model Number 8700-0752

Device Problems Device Stops Intermittently (1599); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/19/2015

Event Type  malfunction  

Manufacturer Narrative

The autopulse platform in complaint was returned to zoll on 02/05/2016 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.Evaluation not complete.

Event Description

It was reported to zoll (b)(4) that during patient use the autopulse platform (s/n (b)(4)) stopped after 10 minutes of compressions.The device was being used on a patient (approximately (b)(6)) down due to cardiac arrest after being involved in an industrial accident.The emts were the second responders and took over from the volunteer bls team.Emt stated that the patient had signs of electrical burns.The bls team was performing manual cpr when the emts arrived and while they were preparing the autopulse (ap) for use.The patient had been down less than 20 minutes.The ap started without issue and performed compressions for 10 minutes, then stopped.Manual cpr was started while the crew changed the battery on the ap.The ap started again without issue and performed compressions for another 10 minutes, at which time it stopped.The emts arrived at the hospital and transferred the patient's care to the er.The patient expired at the hospital.The emt crew arrived back at the station and changed the battery once again on the ap.They tested the ap with a mannequin, which it performed with no problems.The ap is checked daily by the crew and the batteries are charged and swapped out every 24 hours.None of the batteries showed any signs of failure.Related mfr 3010617000-2016-00106 (s/n (b)(4)).

Manufacturer Narrative

The li-ion battery (s/n (b)(4)) was returned to zoll (b)(4) for evaluation.Visual inspection was performed and no physical damage was noted to the battery.The battery passed all functional testing criteria.The reported complaint was not confirmed.The root cause for the reported user experience is related to the autopulse used.

• Brand Name: AUTOPULSE® LI-ION BATTERY
• Type of Device: LI-ION BATTERY, PRODUCT CODE: DRM
• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 5460353
• MDR Text Key: 39019677
• Report Number: 3010617000-2016-00107
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/27/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2016
• 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
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 02/05/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/28/2014
• 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