MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2011-07-15 for STERI-PROBE 491B 39622 manufactured by Cincinnati Sub-zero Products, Inc..
[2164122]
The pt was on total body cooling and during the course of her three day cooling the machine shut off three times and alarmed "check probe". The nurse was able to re-start the machine without difficulty the first three times. The fourth time the machine shut off at approx 48 hours into cooling and alarmed "check probe". I was contacted by the nurse caring for the pt after she could not get the machine to restart. I advised her to replace the probe, which she did. No further concerns were experienced. The probe was not changed after the first three alarms because the machine was easily re-started and to minimize the discomfort to the pt. Cooling should not be interrupted for more than 30 mins. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
[9262770]
The related complaint (b)(4) was received on (b)(4) 2011 and was identified as non-reportable. However, upon receiving user facility report, we decided to report the event in response to the user facility report received from fda on (b)(4) 2011. The probe lot number (d722015) was traced back to alpha sensors, inc as the mfr. Our investigation shows that when we moved the probe slightly from side to side, the pt temp display became erratic and would not maintain a constant reading. Once movement of the probe stopped, the pt temp reading again responded as expected. The failure mode was confirmed similar to one experienced by the probes in the past. The probe had an intermittent connection at the rj-ll connector due to a mfg defect by alpha sensors, inc. Csz made these probes obsolete in (b)(4) 2009 and has scrapped all probes in stock. Csz is no longer a mfr of temp probes, however, csz distributes temp probes manufactured by measurement specialties. In (b)(4) 2009, csz implemented a correction that was communicated to the customer who have filed a complaint and to whom who have ordered new temp probes. Csz is reviewing for field replacement where suspect lot number devices have been shipped prior to 2009. As soon as the recall decision is made, fda will be notified.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1516825-2011-00010 |
| MDR Report Key | 2217143 |
| Report Source | 00 |
| Date Received | 2011-07-15 |
| Date of Report | 2011-06-15 |
| Date of Event | 2011-05-28 |
| Date Mfgr Received | 2011-06-15 |
| Device Manufacturer Date | 2007-10-01 |
| Date Added to Maude | 2011-08-31 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PRADEEP GUPTA |
| Manufacturer Street | 12011 MOSTELLER RD. |
| Manufacturer City | CINCINNATI OH 45241 |
| Manufacturer Country | US |
| Manufacturer Postal | 45241 |
| Manufacturer Phone | 5137728810 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERI-PROBE |
| Generic Name | RECTAL/ESOPHAGEAL TEMPERATURE PROBE |
| Product Code | BZT |
| Date Received | 2011-07-15 |
| Returned To Mfg | 2011-06-17 |
| Model Number | 491B |
| Catalog Number | 39622 |
| Lot Number | D722015 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CINCINNATI SUB-ZERO PRODUCTS, INC. |
| Manufacturer Address | CINCINNATI OH 45241 US 45241 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2011-07-15 |