MAUDE Adverse Event Report: MEDIBO MEDICAL PRODUCTS NV SARA PLUS; LIFT, PATIENT, NON-AC-POWERED

Model Number HEP0001-UK

Device Problem Sparking (2595)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/09/2021

Event Type  malfunction  

Manufacturer Narrative

The charger power cord was mechanically damaged, the insulation was broken.It contributed to occurring the sparks.The investigation is in progress.The conclusions will be provided within the follow-up report once the investigation is completed.

Event Description

Arjo received allegation from the customer representative about sparks from the power cord of the sara plus lift charger.The power cord had damaged insulation.No injury was reported.

Manufacturer Narrative

Arjo received an allegation from the customer representative that sparks came from the power cord of the sara plus lift charger.No injury was reported.An arjo technician during an on-site visit checked the device and found the power cord of the battery charger was mechanically damaged.The cable had damaged insulation and internal wire was exposed and broken.Based on the photographic evidence, it seems the most probable that the cable was pinched by some external object.However, this hypothesis cannot be confirmed as the circumstances of the cable being damaged remains unknown.The instruction for use for sara plus active lift concerns information for usage of the device: before every use: "visually inspect sara plus.If any part is damaged - do not use the product"; weekly: "a general visual inspection of all external parts should be carried out, and all functions should be tested for correct operation, to make sure that no adverse damage has occurred during use." arjo recommends that sara plus is maintained at regular intervals.Following the preventive maintenance schedule service of the equipment should be conducted every 12 months: "examine the charger and wires for integrity and connections." the power cord was found to be damaged and from that perspective, the device did not meet performance specification.The device was not used by the patient.No injury or other medical consequences occurred.The complaint was assessed as reportable due to indication about occurring the sparks from the power cord cable with damaged insulation.

• Brand Name: SARA PLUS
• Type of Device: LIFT, PATIENT, NON-AC-POWERED
• Manufacturer (Section D): MEDIBO MEDICAL PRODUCTS NV; heikant 5; hamont-achel BE-39 30; BE BE-3930
• Manufacturer (Section G): MEDIBO MEDICAL PRODUCTS NV; heikant 5; hamont-achel BE-39 30; BE BE-3930
• Manufacturer Contact: katarzyna bobrow ; ks. wawrzyniaka 2; komorniki 62-05-2 ; PL 62-052 ; 668046472
• MDR Report Key: 13167342
• MDR Text Key: 283775074
• Report Number: 3007420694-2022-00001
• Device Sequence Number: 1
• Product Code: FSA
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/31/2022

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: HEP0001-UK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/09/2021
• Initial Date FDA Received: 01/05/2022
• Supplement Dates Manufacturer Received: 12/09/2021
• Supplement Dates FDA Received: 01/31/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2008
• 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