MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other report with the FDA on 2020-02-12 for VIKING M VIKINGM manufactured by Liko Ab.
[185551150]
A hillrom service technician attempted to obtain the serial number of the lift, however was told that the serial number of the lift was not recorded at the time of the event. The facility biomed assessed the lift at the time of the incident and found it to be working as intended and attributed the event to use error. Per the viking? M mobile lift? 7en137107 (rev. 3) safety instructions: unbalanced lifting poses a tipping risk and may damage the lift equipment! Operation instructions: note: when lifting, the wheels should be unlocked so that the lift can be moved to the patient? S center of gravity. Locked wheels during lifting can increase the risk of tipping. Additionally, the viking? M mobile lift complies with the en iso 10535:2006 requirements for static stability. Based on this information no further action is required.
Patient Sequence No: 1, Text Type: N, H10
[185551151]
Hillrom received a report stating a (b)(6) year old female nursing home patient was being transferred from the chair to the bed using a viking m mobile lift. The complainant (patient? S attorney representative/rn) alleged the lift tipped, resulting in the sling bar striking the patient? S head in (b)(6) 2018. The patient was transferred to the hospital. The complainant indicated the patient was diagnosed with a closed head injury confirmed via ct scan and discharged from the hospital 3 days later to another long term care facility. The lift was located at the account. This report was filed in our complaint handling system as complaint (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8030916-2020-00007 |
| MDR Report Key | 9699904 |
| Report Source | COMPANY REPRESENTATIVE,OTHER |
| Date Received | 2020-02-12 |
| Date of Report | 2020-02-05 |
| Date of Event | 2018-03-11 |
| Date Mfgr Received | 2020-01-07 |
| Date Added to Maude | 2020-02-12 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | BETH GRACEFFA |
| Manufacturer Street | 1069 STATE ROUTE 46 EAST |
| Manufacturer City | BATESVILLE IN 47006 |
| Manufacturer Country | US |
| Manufacturer Postal | 47006 |
| Manufacturer Phone | 3122337700 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VIKING M |
| Generic Name | NON-AC POWERED PATIENT LIFT |
| Product Code | FSA |
| Date Received | 2020-02-12 |
| Model Number | VIKINGM |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | LIKO AB |
| Manufacturer Address | NEDRE VAGEN 100 LULEA, NORRBOTTENS LAN [SE-25] SW |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2020-02-12 |