MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2019-01-25 for AUTOCLAVABLE INTERNAL HANDLES (MSERIES) 8011-0501-01 8011050101 manufactured by Zoll Medical Corporation.
[134083031]
The complainant was contacted for return of the device. The customer has responded and indicated the internal handles were scrapped onsite and will not be returning to zoll..
Patient Sequence No: 1, Text Type: N, H10
[134083032]
Complainant alleged that during a routine shift check by a clinician, the associated defibrillator failed to discharge using the discharge button on these internal handles. Complainant indicated that there was no patient involvement in the reported malfunction. Please reference medwatch report 1220908-2019-00254 for a similar event reported from the same customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1220908-2019-00255 |
| MDR Report Key | 8277381 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2019-01-25 |
| Date of Report | 2019-01-21 |
| Date Mfgr Received | 2019-01-21 |
| Device Manufacturer Date | 2018-01-01 |
| Date Added to Maude | 2019-01-25 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Street | 269 MILL ROAD |
| Manufacturer City | CHELMSFORD MA 01824 |
| Manufacturer Country | US |
| Manufacturer Postal | 01824 |
| Manufacturer Phone | 9784219552 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AUTOCLAVABLE INTERNAL HANDLES (MSERIES) |
| Generic Name | INTERNAL PADDLE |
| Product Code | LDD |
| Date Received | 2019-01-25 |
| Model Number | 8011-0501-01 |
| Catalog Number | 8011050101 |
| Lot Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL MEDICAL CORPORATION |
| Manufacturer Address | 269 MILL ROAD CHELMSFORD MA 01824 US 01824 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-25 |