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

Model Number MODEL 100

Device Problem Device Operational Issue (2914)

Patient Problem No Patient Involvement (2645)

Event Date 05/26/2016

Event Type  malfunction  

Manufacturer Narrative

The li-ion battery (s/n (b)(4)) was returned to zoll for evaluation.Visual inspection of the returned li-ion battery was performed and found no physical damage noted upon receipt.Battery archive review shows battery was inserted into and out of the battery charger during the reported event on (b)(6) 2016 for few seconds showing no fault error.Before the (b)(6), there is a low battery, glitch recorded on (b)(6) and a clock glitch after that.The clock glitch indicates that the battery has lost its history track of date and time.There were also couple of charge cycle conditioning cancellation noted on (b)(6) and multiple in and out battery insertion events seen on (b)(6) 2016.However there were no errors noted.During functional testing, the battery was inserted into a good known multi chemistry charger and battery was charged successfully showing 4 green led lights.The battery was then functionally run on a good known autopulse platform using a large resuscitation test fixture (lrtf) for about 50 minutes without any issues.The platform performed compression successfully with li-ion battery (s/n (b)(4)).In summary, the reported complaint of the li-ion battery will not power up an autopulse is not confirmed during functional testing.The battery passed was charged successfully with a good known multi-chemistry charger and passed the functional testing with a good known auto pulse using a large resuscitation test fixture (lrtf).There were no device deficiencies found during evaluation that could have caused or contributed to the reported complaint.

Event Description

The customer reported that during shift check, the li-ion battery would not power on the autopulse platform.The battery showed as fully charged.No patient involvement was reported.

• 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: 5740723
• MDR Text Key: 47902415
• Report Number: 3010617000-2016-00428
• 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: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MODEL 100
• Device Catalogue Number: 8700-0752-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/26/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/21/2016
• 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