MAUDE Adverse Event Report: ARJOHUNTLEIGH POLSKA SP. Z.O.O. SLINGS, CLIP

Model Number MAA2000M-XL

Device Problems Break (1069); Off-Label Use (1494); Inadequate or Insufficient Training (1643)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

Arjohuntleigh received a customer complaint where it was indicated that during the pt's transfer from the bed to the wheelchair using the hoyer lift (not arjohuntleigh lift), the trim reportedly pulled away from the main body of the sling on both sides (approximately 8 inches on the left and 4 inches on the right side).The pt involved in the incident was a female with the weight (b)(6) lbs and received no injury as a consequence of the event.Reference mfr: 3007420694-2014-00072.

Manufacturer Narrative

(b)(4).This appears to be a "malfunction" type of event (h1) not because there was a technical malfunction of the device, but since due to a use error the device did not perform as intended.Additional info will be provided following the conclusion of the manufacturer's investigation.

• Brand Name: SLINGS, CLIP
• Manufacturer (Section D): ARJOHUNTLEIGH POLSKA SP. Z.O.O.; ul. ks. piotra wawrzyniaka 2; komorniki 6205 2; PL 62052
• Manufacturer (Section G): ARJOHUNTLEIGH POOLSKA SP. Z.O.O.; ul, ks. piotra wawizyniaka 2; komomiki 6205 2; PL 62052
• Manufacturer Contact: pamela wright ; 12625 wetmore; suite 308; san antonio, TX 78247 ; 2102787040
• MDR Report Key: 3952039
• MDR Text Key: 4608288
• Report Number: 1419652-2014-00173
• Device Sequence Number: 1
• Product Code: IKX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/03/2014,06/05/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MAA2000M-XL
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/03/2014
• Distributor Facility Aware Date: 06/05/2014
• Event Location: Hospital
• Date Report to Manufacturer: 07/03/2014
• Date Manufacturer Received: 06/05/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other