MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-07-24 for SSCOR SUCTION DEVICES 2100S manufactured by Sscor, Inc..
[114938459]
Device reported was manufactured on 11/10/2009, device still had the original battery which is over 9 years old. Sscor's manual/labeling recommends that device batteries be replaced every 3 years and to keep the device on charge at all times. The only way to assure the battery has a functional capacity, is to perform the battery check suggested on the sscor manual. Sscor sent user a replacement battery as good faith. The user replaced the battery on the device and it worked to specification. No patient details were provided to sscor.
Patient Sequence No: 1, Text Type: N, H10
[114938460]
Per customer (user): "b shift passed along some information this morning in regards to the suction units on m61. Apparently they had a cpr call and both suction units (red bag and wall mount) died. They said the red bag unit worked for about 2 minutes, and the wall mount worked for only a couple seconds. Call was for a patient in cardiac arrest, issue with device did not contribute to the patients outcome. Several suction units were on scene and available during the emergency. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2022724-2018-00002 |
| MDR Report Key | 7716860 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-07-24 |
| Date of Report | 2018-07-23 |
| Date Mfgr Received | 2018-06-24 |
| Device Manufacturer Date | 2009-11-10 |
| Date Added to Maude | 2018-07-24 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. MAIRA OJEDA |
| Manufacturer Street | 11064 RANDALL ST. |
| Manufacturer City | SUN VALLEY CA 91352 |
| Manufacturer Country | US |
| Manufacturer Postal | 91352 |
| Manufacturer Phone | 8185044054 |
| Manufacturer G1 | SSCOR, INC. |
| Manufacturer Street | 11064 RANDALL ST. |
| Manufacturer City | SUN VALLEY CA 91352 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 91352 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SSCOR SUCTION DEVICES |
| Generic Name | S-SCORT? TEN PORTABLE SUCTION |
| Product Code | BTA |
| Date Received | 2018-07-24 |
| Model Number | 2100S |
| Catalog Number | 2100S |
| Lot Number | N/A |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SSCOR, INC. |
| Manufacturer Address | 11064 RANDALL ST. SUN VALLEY CA 91352 US 91352 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-07-24 |