MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00 report with the FDA on 2014-10-24 for DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE E-CAIO manufactured by Ge Healthcare Finland Oy.
[4962606]
The customer reported an e-caio module sparked when attached to the main central processing unit. Noted during a check out of the product.
Patient Sequence No: 1, Text Type: D, B5
[12391137]
(b)(4). A follow-up report will be submitted when the investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
[28711158]
The customer sent the module to depot repair and the central processing unit (cpu) board of the module was found to be the cause. Module was repaired in depot so further investigation cannot be done. The root cause for the cpu board remain unclear. The reported issue is possible when gas module cpu board is misaligned and d-connector metal housing makes contact to monitor connector pins.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 9610105-2014-00016 |
| MDR Report Key | 4199878 |
| Report Source | 00 |
| Date Received | 2014-10-24 |
| Date of Report | 2014-10-10 |
| Date Mfgr Received | 2014-11-26 |
| Date Added to Maude | 2014-11-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DEB LAHR |
| Manufacturer Street | 540 W. NORTHWEST HWY |
| Manufacturer City | BARRINGTON IL 60010 |
| Manufacturer Country | US |
| Manufacturer Postal | 60010 |
| Manufacturer Phone | 8472774472 |
| Manufacturer G1 | GE HEALTHCARE FINLAND OY |
| Manufacturer City | HELSINKI, |
| Manufacturer Country | FI |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DATEX-OHMEDA S/5 COMPACT AIRWAY MODULE E-CAIO |
| Generic Name | ANALYZER, GAS, OXYGEN, GASEOUS-PHASE |
| Product Code | CCL |
| Date Received | 2014-10-24 |
| ID Number | 6538926 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GE HEALTHCARE FINLAND OY |
| Manufacturer Address | HELSINKI, FI |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-10-24 |