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

Model Number 8700-0752-01

Device Problem Failure to Run on Battery (1466)

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

Event Date 09/20/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

As reported, during shift check, the user facility biomed stated that the autopulse li-ion battery (sn (b)(6)) showed green leds (fully charged) but did not powered on the autopulse platform once inserted.No patient involvement.

• 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: noemi schambach ; 2000 ringwood avenue; san jose, CA 95131 ; 4085412140
• MDR Report Key: 7967904
• MDR Text Key: 123805990
• Report Number: 3010617000-2018-01052
• Device Sequence Number: 1
• Product Code: DRM
• UDI-Device Identifier: 00849111001823
• UDI-Public: 00849111001823
• Combination Product (y/n): N
• Reporter Country Code: ID
• PMA/PMN Number: K112998
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/15/2018
• 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?: Yes
• Date Manufacturer Received: 09/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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