MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-02-19 for BILITX LIGHT SOURCE 1041725 manufactured by Philips Medical Systems.
[100403161]
Philips healthcare received a complaint stating that a bilitx device left a burn on lumbar spine and sacrum. The patient was reportedly admitted into the hospital with burns over 8% of the body. The customer stated that the patient received a mri of the spine and iv antibiotics. The customer also stated that the treatment is in progress, further evaluation and work up is pending. It is unknown at this time if the device malfunctioned and if this malfunction could cause or contribute to a death/serious injury should it recur. The customer stated the device is not available for philips to evaluate. Based on a complete review of the complaint allegation, philips healthcare has determined that the reported issue requires further investigation. Once additional information is received, a follow-up additional information report will be filed to detail the findings and the need for any possible further action.
Patient Sequence No: 1, Text Type: N, H10
[100403162]
The customer reported that the baby was treated with a bilitx blanket and notice a burn on lumbar spine and sacrum. The baby was admitted into the hospital. Customer stated baby has a burn of 8% of the body.
Patient Sequence No: 1, Text Type: D, B5
[105523855]
The complaint issue alleged by the customer was not able to be confirmed because the device was not returned to the manufacturer for evaluation. Per a voicemail from the customer, he and the doctor he spoke with feel that this was not a burn or the fault of the device. The patient was given iv antibiotics and transferred to a different hospital with a pediatric vascular anomaly team. No treatment was given for the rash/burn. A pediatric surgeon also saw the baby and feels the baby has a vascular abnormality, possible hemangioma. The customer has not responded to multiple attempts to have the device returned for evaluation and the customer stated they feel the device did not malfunction. The parents of the patient were using the device at home at the time of the incident. It is unknown if the device was being used correctly. The device is in storage at the customer site per risk assessment (b)(4): temperature testing has verified that the phototherapy panel maintains a safe temperature during phototherapy and the surface temperature of led light engine during operation is not hot enough to cause a burn. No product malfunction can be determined. No further action or investigation is warranted. If the product is returned this complaint will be opened to investigate.
Patient Sequence No: 1, Text Type: N, H10
[105523856]
The customer reported that the baby was treated with a bilitx blanket and notice a burn on lumbar spine and sacurm. The baby was admitted into the hospital. Customer stated baby has a burn of 8% of the body. There was a report of a serious injury. The patient was given iv antibiotics and transferred to a different hospital with a pediatric vascular anomaly team. No treatment (i. E. Salve or ointment) was given for the rash/burn. Per the customer, he and the doctor he spoke with feel that this was not a burn or the fault of the device. The product was in use when the reported problem occurred.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218950-2018-01620 |
| MDR Report Key | 7280744 |
| Date Received | 2018-02-19 |
| Date of Report | 2018-01-23 |
| Date of Event | 2018-01-22 |
| Date Mfgr Received | 2018-01-23 |
| Device Manufacturer Date | 2015-07-08 |
| Date Added to Maude | 2018-02-19 |
| 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 | MR. ROBERT CORNING |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal | 01810 |
| Manufacturer Phone | 9786871501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BILITX LIGHT SOURCE |
| Generic Name | NEONATAL PHOTOTHERAPY |
| Product Code | LBI |
| Date Received | 2018-02-19 |
| Model Number | 1041725 |
| Operator | PATIENT FAMILY MEMBER OR FRIEND |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Address | 3000 MINUTEMAN ROAD ANDOVER MA 01810 US 01810 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2018-02-19 |