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The customer alleged that the otoscope was not working, there was damage to its cable, burn marks on the plug and it trips out other electricals when plugged in.No injury or delay was reported.Hillrom has requested that the device be returned by the customer to allow for investigation by the manufacturing site.The results of this investigation are pending.No further information is available on the device.The investigation is ongoing and the device is being returned to the manufacturer for investigation.If any additional relevant information is identified following completion of the investigation, the additional relevant information will be submitted in a supplemental report.
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The customer alleged that the otoscope was not working, there was damage to its cable, burn marks on the plug and it trips out other electricals when plugged in.No injury or delay was reported.This report was filed in our complaint handling system as complaint #(b)(4).
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The customer alleged that the otoscope was not working, there was damage to its cable, burn marks on the plug and it trips out other electricals when plugged in.No injury or delay was reported.This report was filed in our complaint handling system as complaint #(b)(4).
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The green series 777 wall transformer is intended to supply power to welch allyn 3.5v instruments.The gs 777 wall transformer is a basic power supply.A usb power cable, a 5w power supply and a 5w adapter plug (region specific) are all required to provide power to the gs 777 wall transformer.The gs777 wall transformer is intended for use in ambulatory and acute care settings.The device is intended for users that are medically qualified, trained healthcare professionals.As per the device¿s instructions for use (ifu) routinely inspect the power cord and accessories for wear, fraying, or other damage.Do not use if you see signs of damage, if the instrument malfunctions, appears not to be working properly, or if you notice a change in performance.Damage found to a device is readily detectable by visual inspection.A clinician would immediately recognize that the device was broken / damaged and would likely remove it from clinical service until the device is repaired or replaced.If the exam light were to be unavailable for use, the clinician would obtain an alternative source of light, which may result in a delay.Such delays are brief and would not result in significant risk to the patient.If a back-up device was unavailable, the patient could be rescheduled or referred to another practice.Should the malfunction of a physically damaged otoscope cable recur the likelihood of serious injury or death to a patient as a result is negligible as it would be apparent to the end user and the device should not be used.The cleaning instructions provided in the instructions for use (ifu) contain the following warnings: electric shock hazard.Do not autoclave the transformer or accessories.Liquids can damage electronics inside the transformer.Prevent liquids from spilling on or dripping into the transformer.If liquids are spilled on or drip into the transformer - dry off excess liquid from the transformer.All welch allyn electrical devices are designed and tested to meet all applicable safety and flammability regulations.The materials used for these devices are ul94v flammability rated self-extinguishing materials.Therefore, it is unlikely that a fire could be started or that these incidents would result in a serious burn injury as a result of the device being hot.The device is compliant with iec 60601-1 standard.Clinical evaluation: no injury or delay was reported.The device ifu states cord, cables, and accessories damaged from prior misuse can affect patient and operator safety.Inspect all cords, cables, and accessories for strain relief wear, fraying, or other damage according to the recommendations presented in the maintenance and service section of this manual.Replace as necessary.Generally, in a healthcare facility, essential or critical equipment is plugged into specific outlets that are indicated either by color (red) or labelling that are designated as an emergency backup power outlet.These outlets are powered by a combination of battery backup and generator power to provide an uninterruptible power supply.Should an allegation of otoscope not working reoccur, a serious injury or death is not likely due to an otoscope is not routinely used life sustaining procedures.Multiple attempts were made to retrieve the device from the customer for further investigation however, the device was never returned by the customer.While the device on this complaint was not returned for evaluation, a previously investigation for a gs 777 unit was performed for a similar incident.There was evidence of degradation due to cleaning.It was identified that between the power supply and adaptor plug assemblies there was a large amount of black powder on the contacting surfaces between the two components, consistent with an arcing event.Some of the power covered the whole surface while some had formed into water mark patterns that can occur as liquid evaporates.The majority of the black powder appears to have originated from the corners of the adaptor plug subassembly.These corners have slightly lifted up separating from the rest of the assembly.One of the corners also has a small amount of plastic missing.The adaptor plug subassembly was opened up and these were several signs that an arcing event occurred within the subassembly (additional black powder residue, a pathway of melted plastic, material missing from the missing tabs and metal debris on the melted plastic).The arcing occurred between the two tabs at the location near the connecting wires that carry in the outlet voltage.If the usb output cable is pointed up, then the arcing location is near the bottom of the subassembly.A series of cleaning scenarios were performed on the power supply and adapter plug subassemblies.When they were connected, on the adapter plug subassembly only it was evident from this cleaning that liquid ingress was possible in-between these sub-assemblies and that liquid was able to migrate inside the power adapter plug subassembly.Cleaning fluid on the external surface completely dried within 1 ¿ 2 minutes.This was significantly longer when the fluid was present in-between the two subassemblies.The root cause was determined to be an electrical arcing event which occurred between the electrical conductive tabs inside the adapter plug subassembly.The arcing event was due to liquid in the subassembly electrically connecting the two tabs.The liquid most likely entered the subassembly as a result of cleaning the device.On the 14 april 2021 the fsca mod1329 was filed with the fda and received reference number res#(b)(4).Hillrom has issued an fsn to impacted consignees informing them of the potential risk associated with inadvertent fluid ingress secondary to the cleaning of power supplies which also provides cleaning recommendations for the power supply.Additionally, hillrom has updated the gs777 instruction for use (ifu) to include the cleaning recommendations.The first round of fsn letters was mailed to the us consignees on the 23 april 2021.
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