MAUDE Adverse Event Report: HOSPIRA COSTA RICA LTD. PLM A+ SPANISH DEVICE NEW RESTART; PUMP INFUSION

Model Number	12391
Medical Device Problem Code	Circuit Failure (1089)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported that the device user (nurse) received an electric shock but there was no adverse event.The customer also reported that the cord was damaged but there were no exposed wires.Testing and investigation confirmed the damaged ac power cord.The power cord was replaced.

• Brand Name: PLM A+ SPANISH DEVICE NEW RESTART
• Common Device Name: PUMP INFUSION
• Manufacturer (Section D): HOSPIRA COSTA RICA LTD.; zona franca global; la aurora heredia, ; CS
• MDR Report Key: 7898127
• Report Number: 9615050-2018-00054
• Device Sequence Number: 1434476
• Product Code: FRN
• UDI-Device Identifier: M3351239104251
• UDI-Public: M3351239104251
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K070398
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/28/2018

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: Health Professional
• Device Model Number: 12391
• Device Catalogue Number: 12391
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/21/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1