MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2006-01-06 for 970 SE-10 HOSPITAL SMART MONITOR manufactured by Respironics, Inc..
[16142895]
Information was received from the repair technician that on evaluation, this device was incapable of sounding the optional remote alarm to alert the caregiver of an event. There was no report of patient harm or injury with this device. The primary alarm on the device was found to operate correctly. Per complaint clarification from the customer the remote alarm option is not utilized by their facility, however the inability of the device to sound the optional alarm could cause or contribute to harm or injury to the intended user. The circuit board was replaced to correct the problem.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2518422-2006-00001 |
| MDR Report Key | 661027 |
| Report Source | 05,07 |
| Date Received | 2006-01-06 |
| Date of Report | 2005-12-17 |
| Date of Event | 2005-12-17 |
| Date Mfgr Received | 2005-12-17 |
| Device Manufacturer Date | 2002-02-01 |
| Date Added to Maude | 2006-01-10 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | LOU KINNEY |
| Manufacturer Street | 1001 MURRY RIDGE LANE |
| Manufacturer City | MURRYSVILLE PA 15866 |
| Manufacturer Country | US |
| Manufacturer Postal | 15866 |
| Manufacturer Phone | 7243874292 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 970 SE-10 HOSPITAL SMART MONITOR |
| Generic Name | INFANT APNEA MONITOR |
| Product Code | BZQ |
| Date Received | 2006-01-06 |
| Returned To Mfg | 2005-12-13 |
| Model Number | 970 SE-10 |
| Catalog Number | 970 SE-10 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 650444 |
| Manufacturer | RESPIRONICS, INC. |
| Manufacturer Address | 1001 MURRY RIDGE LN. MURRYSVILLE PA 156688550 US |
| Baseline Brand Name | 970 SE-10 HOSPITAL SMART MONITOR |
| Baseline Generic Name | INFANT APNEA MONITOR |
| Baseline Model No | 970 SE-10 |
| Baseline Catalog No | 970 SE-10 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-01-06 |