MAUDE Adverse Event Report: ARJO HOSPITAL EQUIPMENT AB SLINGS, LOOP

Model Number MLA3000-M

Device Problems Break (1069); Use of Device Problem (1670); Human Factors Issue (2948)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/17/2014

Event Type  malfunction  

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).Additional info will be provided upon conclusion of the mfr's investigation.

• Brand Name: SLINGS, LOOP
• Manufacturer (Section D): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer (Section G): ARJO HOSPITAL EQUIPMENT AB; verkstadsvagen 5; eslov 2412 1; SW 24121
• Manufacturer Contact: pamela wright ; 12625 wetmore, ste 308; san antonio, TX 78247 ; 2102787000
• MDR Report Key: 3659341
• MDR Text Key: 4320028
• Report Number: 9611530-2014-00012
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 02/14/2014,01/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MLA3000-M
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/14/2014
• Distributor Facility Aware Date: 01/17/2014
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/14/2014
• Date Manufacturer Received: 01/17/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2012
• 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