MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-31 for C-MAC 8402X manufactured by Karl Storz Gmbh & Co. Kg Tuttlingen, Germany.
[53665131]
We evaluated the electronic module and found that some of the male pins on mating connector of blade were bent significantly to cause misalignment with the sockets on this module. The resulting impact caused one of the sockets to split and partially become pushed back into the plastic connector body. As a result, the integrity of the electrical connection was compromised. This fault was ultimately caused by improper care and handling of the equipment.
Patient Sequence No: 1, Text Type: N, H10
[53665132]
Allegedly, doctor was performing an intubation on a (b)(6) baby; the light source failed once blade was placed in patient. When the handle was turned, image became intermittent. The staff didn't have a backup electronic module, so they swapped out the blade to see whether that would solve the problem. They used a competitor's glidescope instead to complete the procedure. Per the hospital, the patient expired, which they believe was related to patient condition, but the delay in switching between blades didn't likely help the situation.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610617-2016-00131 |
| MDR Report Key | 5919593 |
| Date Received | 2016-08-31 |
| Date of Report | 2016-08-03 |
| Date of Event | 2016-08-02 |
| Date Mfgr Received | 2016-08-03 |
| Date Added to Maude | 2016-08-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 0 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. SUSIE CHEN |
| Manufacturer Street | 2151 E. GRAND AVENUE |
| Manufacturer City | EL SEGUNDO CA 902455017 |
| Manufacturer Country | US |
| Manufacturer Postal | 902455017 |
| Manufacturer Phone | 4242188201 |
| Manufacturer G1 | KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY |
| Manufacturer Street | MITTLESTRASSE 8, 78503 |
| Manufacturer City | TUTTLINGEN, GERMANY, |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | C-MAC |
| Generic Name | ELECTRONIC IMAGING MODULE |
| Product Code | OGH |
| Date Received | 2016-08-31 |
| Returned To Mfg | 2016-08-08 |
| Model Number | 8402X |
| Catalog Number | 8402X |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY |
| Manufacturer Address | MITTLESTRASSE 8, 78503 TUTTLINGEN, GERMANY, GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2016-08-31 |