MAUDE Adverse Event Report: SMITHS MEDICAL ASD,INC CADD ACCESSORIES BATTERY; ACCESSORIES, PUMP, INFUSION

Model Number	BATTERY PACK, RECHARGEABLE, LITHIUM ION, 3.7V, 1400
Medical Device Problem Code	Charging Problem (2892)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device analysis is done by supplier, which is ultralife corp.
Event or Problem Description
Information received a smiths medical cadd assessories battery will only charge and accept 75%.Battery was changed on (b)(6) 2019.No patient adverse events reported.
Additional Manufacturer Narrative
Complaint of cadd accessories battery only charging only to 75% is not reportable to fda.This is a cadd accessory and battery not charging would be discovered prior to use or change of battery would be implemented.Correction on file to non reportable to fda.
Event or Problem Description
Report filed reportable as this a cadd accessory and battery lithium not charging 75% is not reportable.Correction being submitted.

• Brand Name: CADD ACCESSORIES BATTERY
• Common Device Name: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD,INC; 6000 lane n; minneapolis MN 55442
• MDR Report Key: 9565750
• Report Number: 3012307300-2020-00092
• Device Sequence Number: 2901882
• Product Code: MRZ
• UDI-Device Identifier: 10610586031212
• UDI-Public: 10610586031212
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072144
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2020

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
• Operator of Device: Other
• Device Model Number: BATTERY PACK, RECHARGEABLE, LITHIUM ION, 3.7V, 1400
• Device Catalogue Number: 21-2160-51
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2019
• Supplement Date Received by Manufacturer: 12/10/2019
• Initial Report FDA Received Date: 01/08/2020
• Supplement Report FDA Received Date: 04/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1