MAUDE Adverse Event Report: ARJO MED AB LTD. SARITA

Model Number KKB3020-US

Device Problem Fail-Safe Problem (2936)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2014

Event Type  malfunction  

Event Description

Initially it was reported by arjohuntleigh representative that lift stuck during use with a patient.The resident had been raised from the toilet and moved to the wheel chair and when the nurse tried to lower the resident into the chair the lift would not lower.The lift made a loud grinding noise and the lift could not be lowered using the emergency lowering button either.The sling was released from the support arms and 3 nurses helped to lower resident into the wheel chair.From received information no injury occurred to the patient or caregiver.

Manufacturer Narrative

(b)(4).Additional information will be provided upon completion of the manufacturer's investigation.(b)(4).

• Brand Name: SARITA
• Manufacturer (Section D): ARJO MED AB LTD.; st. catherine st.; glocester GL1 2SL; UK GL1 2SL
• Manufacturer (Section G): ARJOHUNTLEIGH POLSKA SP. Z O.O.; ul ks. piotra wawzyniaka 2; komomiki PL-6 2052; PL PL-62052
• Manufacturer Contact: pamela wright ; 12625 wetmore; ste 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 4169368
• MDR Text Key: 4871682
• Report Number: 9611530-2014-00075
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Remedial Action: Notification
• Type of Report: Initial
• Report Date: 09/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KKB3020-US
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/30/2014
• Distributor Facility Aware Date: 09/02/2014
• Device Age: 12 NA
• Event Location: Nursing Home
• Date Report to Manufacturer: 09/30/2014
• Date Manufacturer Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2002
• 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
• Patient Age: 90 YR
• Patient Weight: 59