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

Model Number BAC1111-01

Device Problems Component Falling (1105); Corroded (1131)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Event Description

It was reported by the company representative that carevo castor fell off the device due to corrosion.No injury or accident happened.Customer noticed this malfunction prior to use.

Manufacturer Narrative

Additional information will be provided following the conclusion of the investigation.(b)(4).

• Brand Name: CAREVO
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan 6205 2; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. ZO.O.; ul. ks. wawrzyniaka 2; komorniki; poznan 0000 6205; PL 000062052
• Manufacturer Contact: pamela wright ; 12625 wetmore; suite 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4554264
• MDR Text Key: 5456520
• Report Number: 3007420694-2015-00048
• Device Sequence Number: 1
• Product Code: FNG
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Repair
• Type of Report: Initial
• Report Date: 02/25/2015,01/28/2015

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?: Yes
• Device Operator: Other
• Device Model Number: BAC1111-01
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/25/2015
• Distributor Facility Aware Date: 01/28/2015
• Event Location: Nursing Home
• Date Report to Manufacturer: 02/25/2015
• Initial Date Manufacturer Received: 01/28/2015
• Initial Date FDA Received: 02/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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