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

Model Number 8700-0752-01

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

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 05/21/2015

Event Type  malfunction  

Event Description

It was reported by a zoll sales representative that autopulse li-ion battery with serial number (sn): (b)(4) held a charge but did not power on the autopulse platform.Other batteries are able to power the platform on.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

The autopulse battery in complaint was returned to zoll on (b)(6) 2015 for investigation.However, investigation is still in progress.A supplemental report will be filed when investigation has been completed.

Manufacturer Narrative

The autopulse battery (s/n (b)(4)) was returned to zoll (b)(4) on 05/26/2015.Investigation results as follows: visual inspection of the returned platform was performed and found no physical damages.During functional testing on a platform, the battery latch on the li-ion battery was difficult to release.Additionally it was difficult to fully insert and lock the battery into the autopulse platform which could have potentially caused the autopulse not to power up.Note that the led on the li-ion battery (s/n (b)(4)) showed a green light when received and post charging confirming that the battery held the charge.Based on the investigation no parts were replaced.In summary the customer's reported complaint that the li-ion battery would not power the autopulse platform was not confirmed during functional testing.Battery works normally to power on a platform, but has difficulty locking itself in the battery compartment of the platform.

• 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: joy patel ; 2000 ringwood ave,; san jose, CA 95131 ; 4084192957
• MDR Report Key: 4849279
• MDR Text Key: 5868605
• Report Number: 3010617000-2015-00336
• Device Sequence Number: 1
• Product Code: DRM
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8700-0752-01
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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