MAUDE Adverse Event Report: MONICA HEALTHCARE LTD NOVII; NOVII POD

Model Number	307-PT-003
Medical Device Problem Code	Fire (1245)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial evaluation is being carried out on novii pod in the (b)(4) but at present we can not repeat the issue.We are awaiting for the failed unit to be returned to our facility in the (b)(4) for evaluation.
Event or Problem Description
On (b)(6).Monica was informed there had been an incident with a novii pod at the (b)(6) hospital in (b)(6) where a pod overheated whilst on charge and began emitting sparks before melting the exterior pod plastic.No-one was hurt.The pod was on charge in a stockroom at the time and a junior nurse was present and heard a pop, followed by sparks and smoke.The l&d manager doused the novii system with a powder fire extinguisher and the hospital fire department was called.Monica's clinical specialist, (b)(6), happened to be at the hospital at the time.The immediate hypothesis was that the lithium-polymer battery within the novii pod could be the cause and the fact that the failure occurred during charging, i.E.At a time when the battery chemistry is most volatile, appeared to support this.

• Brand Name: NOVII
• Common Device Name: NOVII POD
• Manufacturer (Section D): MONICA HEALTHCARE LTD; unit 8 interchange 25; business park, bostocks lane; nottingham, nottinghamshire NG10 5QG; UK NG10 5QG
• MDR Report Key: 6110917
• Report Number: 3006340424-2016-00001
• Device Sequence Number: 18888119
• Product Code: HGM
• UDI-Device Identifier: 05060433670060
• UDI-Public: 05060433670060
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K140862
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Device Unattended
• Device Model Number: 307-PT-003
• Device Lot Number: 500871
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2016
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2016
• Initial Report FDA Received Date: 11/17/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1