MAUDE Adverse Event Report: NIHON KOHDEN CORPORATION UPS; UNINTERRUPTIBLE POWER SUPPLY

Device Problems Battery Problem (2885); Power Problem (3010)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/11/2020

Event Type  malfunction  

Manufacturer Narrative

The customer reported that their facility experienced a power outage during which their uninterruptible power supply (ups) experienced a battery failure.No harm or injury was reported.The customer will be purchasing a new battery in order to mitigate this issue.Nihon kohden continues to investigate the reported event.Nihon kohden will submit a supplemental report in accordance with 21 cfr section 803.56 when additional information becomes available.The following fields contain no information (ni), as attempts to obtain information were made, but not provided: concomitant medical products.The following fields contain no information (ni), as attempts to obtain information were made but not provided: model name, catalog name, serial number, unique identifier (udi) number, approximate age of the device.Device model was not provided, so the age of the device is unknown, pma/510(k) number, device manufacturer date.

Event Description

The customer reported that their facility experienced a power outage during which their uninterruptible power supply (ups) experienced a battery failure.

Manufacturer Narrative

Details of complaint: the customer reported that their facility experienced a power outage during which their uninterruptible power supply (ups) experienced a battery failure.No patient harm or injury was reported.Investigation summary: an uninterruptible power supply (ups) is used to prevent sudden power loss to connected machines in the case of power outage.Should the ups fail to hold a charge or become defective, this would result in sudden power loss of the connected devices.Upss are a third-party device and are not nihon kohden devices.The battery in the ups is susceptible to wear and tear.Battery replacement is a known resolution for ups failure.

Event Description

The customer reported that their facility experienced a power outage during which their uninterruptible power supply (ups) experienced a battery failure.

• Brand Name: UPS
• Type of Device: UNINTERRUPTIBLE POWER SUPPLY
• Manufacturer (Section D): NIHON KOHDEN CORPORATION; attn: shama mooman; 1-31-4 nishiochia; shinjuku-ku, tokyo 161-8 560; JA 161-8560
• Manufacturer (Section G): NIHON KOHDEN TOMIOKA CORPORATION; attn: shama mooman; 1-1 tajino; tomioka city, gunma 370-2 314; JA 370-2314
• Manufacturer Contact: shama mooman ; safety mgmt dept, quality mgmt; seibu bldg 2, 4th floor 1-11-2; kusunokidai tokorozawa, saitama 359-8-580 ; JA 359-8580
• MDR Report Key: 10237358
• MDR Text Key: 198360470
• Report Number: 8030229-2020-00360
• Device Sequence Number: 1
• Product Code: MHX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 07/06/2020,02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/06/2020
• Distributor Facility Aware Date: 06/11/2020
• Event Location: Hospital
• Date Report to Manufacturer: 07/06/2020
• Initial Date Manufacturer Received: 06/11/2020
• Initial Date FDA Received: 07/06/2020
• Supplement Dates Manufacturer Received: 02/01/2023
• Supplement Dates FDA Received: 02/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1