MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z O.O. MINSTREL (INCL. MINERVA); NONE

Model Number TML 100

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/24/2014

Event Type  malfunction  

Event Description

It was reported by the company representative: while moving the pt from pram to the bed, the right leg unscrewed off the chassis and the device leg was closed over the normal range, this caused a loss of stability.Ref mfr: 3007420694-2014-00063.

• Brand Name: MINSTREL (INCL. MINERVA)
• Type of Device: NONE
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul. ks. piotra wawrzyniaka 2; komorniki 6205 2; PL 62052
• Manufacturer (Section G): ARJO, INC.; 50 north gary ave., suite a; roselle IL 60172 168
• Manufacturer Contact: 50 north gary ave., suite a; roselle, IL 60172-1684
• MDR Report Key: 3888115
• MDR Text Key: 4424880
• Report Number: 1419652-2014-00142
• Device Sequence Number: 1
• Product Code: FNG
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/29/2014,04/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: TML 100
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/29/2014
• Distributor Facility Aware Date: 04/30/2014
• Device Age: 15 YR
• Event Location: Nursing Home
• Date Report to Manufacturer: 05/29/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 59 YR
• Patient Weight: 95