MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2014-12-12 for OEM EST 18FR 400 SERIES 100CS 81-041418 manufactured by Deroyal Cientifica De Latinoamerica Sa Globla Park.
[5237644]
Temperature probes are not reading properly. Esophageal stethoscopes. Vital temp 18fr ref 1011eu lot 9475716. The first failure occurred when i placed the es, then hooked up the monitor lead and got double dashes, i. E. No reading. I did some troubleshooting that indicated that the lead wire and the monitor were ok. I decided it must have been an isolated defect, because i hadn't seen it before, but decided to check the probes at room temperature prior to inserting what might be a useless monitor into someone's esophagus. There's a small but non-zero risk of complications from inserting even a functioning es into a patient. I opened this package and tested the probe. It read room temperature correctly, so i inserted the es into my patient. At first, the probe gave credible readings in the 35-367 c range. Suddenly the temperature began to vacillate all over the place, reading anywhere from 19 to 36 c. This was not associated with cautery or any other "normal" source of interference. I cannot rule out penetration of the liquid-proof barrier to the es at this time, which might expose the patient to stray currents induced in the lead wire or a spurious path to ground in the cautery.
Patient Sequence No: 1, Text Type: D, B5
[12723733]
No further information is available at this time. Will provide follow ups if information becomes available.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9613793-2014-00010 |
| MDR Report Key | 4359855 |
| Report Source | 05 |
| Date Received | 2014-12-12 |
| Date of Report | 2014-12-12 |
| Date of Event | 2014-11-03 |
| Date Facility Aware | 2014-11-03 |
| Report Date | 2014-12-12 |
| Date Mfgr Received | 2014-11-19 |
| Date Added to Maude | 2015-01-05 |
| 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 | 0 |
| Manufacturer Phone | 8653622333 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWEL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37849 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | OEM EST 18FR 400 SERIES 100CS |
| Generic Name | STETHOSCOPE, ESOPHAGEAL, WITH ELECTR |
| Product Code | BZT |
| Date Received | 2014-12-12 |
| Catalog Number | 81-041418 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL CIENTIFICA DE LATINOAMERICA SA GLOBLA PARK |
| Manufacturer Address | 602 PARKWAY P.O. BOX 180-3006 LA AURORA, HEREDIA CS |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-12-12 |