MAUDE Adverse Event Report: ZOLL CIRCULATION INC AUTOPULSE LI-ION BATTERY; COMPRESSOR, CARDIAC, EXTERNAL

Model Number 8700-0752-01

Device Problem Use of Device Problem (1670)

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

Event Date 01/15/2019

Event Type  malfunction  

Manufacturer Narrative

The reported event of the autopulse li-ion battery (sn (b)(4)) was not confirmed through functional testing and archive data review.There were no device deficiencies found during evaluation of the returned autopulse li-ion battery that could have caused or contributed to the reported complaint.The reported issue could not be duplicated therefore, the root cause could not be confirmed.Upon visual inspection, no physical damage was observed, and four green lights were lit on incoming inspection.The battery passed charging in a known good multi chemistry charger.Four green lights were lit after successful charging.Battery was also tested in a known good autopulse platform using large resuscitation test fixture with compression for about 38 minutes and the battery passed the test with no issue.The archive data review showed no discrepancies.

Event Description

As reported, for patient use, on (b)(6) 2019, the autopulse li-ion battery (sn (b)(4)) was placed in the autopulse platform.The platform displayed a manufacturer's warning and wouldn't initialize.The battery was fully charged prior to inserting in to the platform and the battery status indicator showed 4 green led's after charging.The crew replaced the battery and the platform performed as intended.The crew inserted the same battery on different autopulse on (b)(6) 2019 and the autopulse performed as intended.No known impact or consequence to patient information was available.

• Brand Name: AUTOPULSE LI-ION BATTERY
• Type of Device: COMPRESSOR, CARDIAC, EXTERNAL
• Manufacturer (Section D): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer (Section G): ZOLL CIRCULATION INC; 2000 ringwood avenue; san jose CA 95131
• Manufacturer Contact: kimthoa nguyen ; 2000 ringwood ave; san jose, CA 95131 ; 4085411030
• MDR Report Key: 8324072
• MDR Text Key: 136151342
• Report Number: 3010617000-2019-00077
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• 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: 02/05/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/08/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/02/2018
• 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