MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. ZO.O. NINUET

Device Problem Insufficient Information (3190)

Patient Problem No Information (3190)

Event Type  No Answer Provided  

Event Description

On (b)(6) 2015 arjohuntleigh has received information from the representative of the (b)(6), that they are investigating the cause of a fatal house fire in (b)(6) 2014, and a role of the minuet 2 bed in it.The investigation police officer indicated that at the moment they are unwilling to release further information.More detailed description of the event, circumstances under which it occurred, name of the customer or serial number of the minuet 2 allegedly to be involved in the event are unfortunately unknown.

Manufacturer Narrative

(b)(4).Additional information will be provided following the release of data from the (b)(6) as further information is required in order to understand the problem and conduct further investigation.(b)(4).

• Brand Name: NINUET
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki 6205 2; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; komorniki 0000 6205; PL 000062052
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247-0000 ; 2102787040
• MDR Report Key: 4473903
• MDR Text Key: 5496045
• Report Number: 3007420694-2015-00024
• Device Sequence Number: 1
• Product Code: LLI
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/21/2015

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?: No
• Device Operator: Other
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/29/2015
• Distributor Facility Aware Date: 01/21/2015
• Date Report to Manufacturer: 01/29/2015
• Initial Date Manufacturer Received: 01/21/2015
• Initial Date FDA Received: 01/30/2015
• 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
• Patient Outcome(s): Other