MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-22 for FSE 2100 SAFELINC SGL HEL 50/C 31479549 manufactured by Covidien.
[26739359]
An investigation is currently under way; upon completion the results will be forwarded.
Patient Sequence No: 1, Text Type: N, H10
[26739360]
It was reported to covidien on (b)(6) 2015 that a customer had an issue with a fetal scalp electrode. The customer reports the fetal spiral electrodes (fse) have failed. As a result we would likely replace the fse each time this occurs. Every time the fse is placed there is a break in the skin of the fetus which poses a potential for infection or bleeding.
Patient Sequence No: 1, Text Type: D, B5
[34560465]
Submit date: 12/08/2015 per lead clinical analyst, upon further assessment of the risk file for this product along with additional clinical evaluation of this specific event, this would not be a reportable event. The lot number for this complaint was provided and a review of a device history record from the same time period has been performed; no peculiarities were noted and all product requirements were met. Prior to a lot being released, it must be deemed acceptable by passing 100% continuity for both the infant and maternal monitoring during in-process inspection. Current manufacturing practices require production to be sampled and inspected based on valid sampling plans. These sampling plans have been reviewed as part of the investigation and have been found to meet the outgoing acceptable quality level (oaql). In addition to sampling and testing, production employees also perform 100% visual inspection as part of manufacturing requirements. A sample was received with this complaint number, consisting of 2-opened empty pouches without fse 2100 safelinc sgl hel 50/c (b)(4) (inside a ziploc polybag) lot 506409x associated with this complaint. Since there was no product available it was not possible to test the part and the condition reported could not be confirmed. The root cause identified is a worn out monitor cable. This attributed to a poor connection and therefore no reading. There have been no design changes to this product within the past year that would contribute to any increased probability for no reading. Production controls are in place to reduce and/or eliminate the possibility of electrode problems that could lead to latent issues such as no reading. An in-servicing visit was scheduled for this client and during the field visit complaint samples collected on site were tested using medtronic? S monitor, simulator and cable and a trace was able to be obtained. From additional information received from the customer, the unit nurses provided additional details of the failures and a particular room was identified as having recurring issues. The customer reported that biomed had checked all monitors; all were found to be in good working condition. The biomed team also had a simulator so an additional investigation was possible. With the use of two simulators and set-
Patient Sequence No: 1, Text Type: N, H10
[34560466]
Ups, it was possible to conduct additional trouble shooting and narrow the failure to the cable. As a result of the testing, 4 cables were found to be faulty. The root cause of the reported failure was related to worn out monitor cables that lead to a poor connection and therefore no reading. There have been no design changes to this product within the past year that would contribute to any increased probability for no reading. Production controls are in place to reduce and/or eliminate the possibility of electrode problems that could lead to latent issues such as no reading. Since this complaint is unconfirmed from the manufacturing perspective but were external assignable causes as of the faulty monitor cables found at the hospital a corrective action of identifying the cables with a unique identifier would help track the movement and duration of use in the unit. In addition, it was recommended that cleaning and handling instructions be provided to the unit to ensure proper handling. This complaint will be recorded for tracking and trending purposes. A corrective action is not deemed necessary at this time. This complaint will be recorded for tracking and trending.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9681860-2015-00009 |
| MDR Report Key | 5095068 |
| Date Received | 2015-09-22 |
| Date of Report | 2015-09-03 |
| Date of Event | 2015-09-01 |
| Date Mfgr Received | 2015-12-08 |
| Date Added to Maude | 2015-09-22 |
| 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 | THOM MCNAMARA |
| Manufacturer Street | 15 HAMPSHIRE STREET |
| Manufacturer City | MANSFIELD MA 02048 |
| Manufacturer Country | US |
| Manufacturer Postal | 02048 |
| Manufacturer Phone | 5084524811 |
| Manufacturer G1 | COVIDIEN |
| Manufacturer Street | 215 HERBERT STREET GANANOQUE |
| Manufacturer City | ONTARIO K7G 2Y7 |
| Manufacturer Country | CA |
| Manufacturer Postal Code | K7G 2Y7 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FSE 2100 SAFELINC SGL HEL 50/C |
| Generic Name | FETAL ELECTRODE |
| Product Code | HBM |
| Date Received | 2015-09-22 |
| Model Number | 31479549 |
| Catalog Number | 31479549 |
| Lot Number | 506409X |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COVIDIEN |
| Manufacturer Address | 215 HERBERT STREET GANANOQUE CA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-09-22 |