MAUDE Adverse Event Report: ZOLL CIRCULATION AUTOPULSE® NIMH BATTERY

Model Number 8700-0702-01

Device Problem Premature Discharge of Battery (1057)

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

Event Date 04/20/2015

Event Type  malfunction  

Event Description

It was reported that during a training, the autopulse li-ion battery did not hold a charge.The battery only lasted for about 5 minutes.It is unknown if the battery faulted in the charger.No patient involvement was reported.No further information was provided.

Manufacturer Narrative

Zoll has not yet received the autopulse battery in complaint for investigation.A supplemental report will be filed if and when the product is returned and investigation has been completed.

Manufacturer Narrative

The autopulse battery s/n (b)(4) was returned to zoll (b)(4) on 05/26/2015 for evaluation.Investigation results as follows: visual inspection: no physical damage noted upon receipt.Functional testing: the (b)(4) battery failed during charging.Conclusion: the customer reported the nimh battery did not last more than 5 minutes during training.Visual inspection was performed and found no physical damage.Archive data is not available on (b)(4) batteries.However during functional testing the (b)(4) failed to charge, confirming the reported complaint.A root cause was not able to be determined.

• Brand Name: AUTOPULSE® NIMH BATTERY
• Type of Device: NIMH 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: 4773360
• MDR Text Key: 21189372
• Report Number: 3010617000-2015-00275
• Device Sequence Number: 1
• Product Code: DRM
• 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,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 8700-0702-01
• Device Catalogue Number: 8700-0702-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2013
• 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