MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2020-01-21 for AUTOCLAVABLE INTERNAL HANDLES (MSERIES) 8011-0501-01 8011050101 manufactured by Zoll Medical Corporation.
[175748274]
Zoll medical corporation has not received the device for evaluation and this complaint is still under investigation.
Patient Sequence No: 1, Text Type: N, H10
[175748275]
Complainant alleged that during a routine shift check by a clinician, the device's internal handles failed to discharge. Complainant indicated that there was no patient involvement in the reported malfunction.
Patient Sequence No: 1, Text Type: D, B5
[186066977]
The complainant was contacted for return of the device. The device has not been returned to zoll for evaluation.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1220908-2020-00077 |
| MDR Report Key | 9612776 |
| Report Source | FOREIGN |
| Date Received | 2020-01-21 |
| Date of Report | 2020-01-02 |
| Date Mfgr Received | 2020-01-02 |
| Device Manufacturer Date | 2018-12-01 |
| Date Added to Maude | 2020-01-21 |
| 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 | 2020-01-21 |
| Model Number | 8011-0501-01 |
| Catalog Number | 8011050101 |
| Lot Number | NA |
| Device Availability | N |
| Device Age | DA |
| 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 | 2020-01-21 |